<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712074</url>
  </required_header>
  <id_info>
    <org_study_id>B2081011</org_study_id>
    <secondary_id>2014-000830-42</secondary_id>
    <nct_id>NCT01712074</nct_id>
  </id_info>
  <brief_title>Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil</brief_title>
  <official_title>A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate&#xD;
      Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil.&#xD;
      The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered&#xD;
      the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and&#xD;
      neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor&#xD;
      re-emergence of neuropsychiatric and cognitive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated October 23, 2015 as pre-specified, interim analysis futility criteria&#xD;
    were met. The termination was not due to safety concerns.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in ADAS-cog13 Total Score at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation</measure>
    <time_frame>Week 4 to Week 18</time_frame>
    <description>Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period</measure>
    <time_frame>Week 4 to Week 16</time_frame>
    <description>Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.&#xD;
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1).</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)</measure>
    <time_frame>Baseline and Week 10</time_frame>
    <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)</measure>
    <time_frame>Baseline and Week 16/Early Termination</time_frame>
    <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern</measure>
    <time_frame>Week 4 to Week 16</time_frame>
    <description>Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value&gt;=300 msec , a PR increase of &gt;=25% (for participants with a baseline value&gt;=200 msec), or with an increase &gt;=50% (for participants with a baseline value&lt;200 msec) were counted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)</measure>
    <time_frame>Baseline and Week 10</time_frame>
    <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)</measure>
    <time_frame>Baseline and Week 16/Early Termination</time_frame>
    <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern</measure>
    <time_frame>Week 4 to Week 16</time_frame>
    <description>Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value&gt;=100 msec , a QRS complex increase of &gt;=25% (for participants with a baseline value&gt;=100 msec), or with an increase &gt;=50% (for participants with a baseline value&lt;100 msec) were counted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)</measure>
    <time_frame>Baseline and Week 10</time_frame>
    <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
  </other_outcome>
  <other_outcome>
    <measure>Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)</measure>
    <time_frame>Baseline and Week 16/Early Termination</time_frame>
    <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern</measure>
    <time_frame>Week 4 to Week 16</time_frame>
    <description>Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.&#xD;
Participants with a post-baseline QTcF absolute value of 450 - &lt;480, 480 - &lt;500, or &gt;=500 mec, or with a post-baseline QTcF increase of 30 - &lt;60 or &gt;=60 msec were counted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pulse Rate Changes From Baseline - Week 6 (Visit 3)</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>BP Changes From Baseline - Week 10 (Visit 4)</measure>
    <time_frame>Baseline and Week 10</time_frame>
    <description>The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pulse Rate Changes From Baseline - Week 10 (Visit 4)</measure>
    <time_frame>Baseline and Week 10</time_frame>
    <description>The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>BP Changes From Baseline - Week 16/Early Termination (Visit 5)</measure>
    <time_frame>Baseline and Week 16/Early Termination</time_frame>
    <description>The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)</measure>
    <time_frame>Baseline and Week 16/Early Termination</time_frame>
    <description>The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern</measure>
    <time_frame>Week 4 to Week 16</time_frame>
    <description>Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participants in Each Category of C-CASA Mapped From the C-SSRS Responses</measure>
    <time_frame>From Screening to Week 18/Early Termination</time_frame>
    <description>Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.&#xD;
C-CASA Event Code: &lt;1&gt; Completed suicide; &lt;2&gt; Suicide attempt; &lt;3&gt; Preparatory acts towards imminent suicidal behavior; &lt;4&gt; Suicidal Ideation; &lt;7&gt; Self-injurious behavior, no suicidal intent.&#xD;
The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).&#xD;
Only participants falling any category of C-CASA events were listed below.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>30 mg QD of PF-05212377</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-05212377 (SAM-760)</intervention_name>
    <description>30 mg QD of PF-05212377 (SAM-760)</description>
    <arm_group_label>30 mg QD of PF-05212377</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo QD</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of probable AD with supportive brain imaging documentation&#xD;
&#xD;
          -  Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10&#xD;
             on the NPI at screening, arising from item scores equal or greater than 2 (frequency X&#xD;
             severity) on at least 2 domains.&#xD;
&#xD;
          -  Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no&#xD;
             intent to change such for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Demonstrate extreme agitation, physical aggression or violence to themselves, their&#xD;
             caregiver, or others, and/or an inability to complete the ADAS-cog assessment at&#xD;
             Screening.&#xD;
&#xD;
          -  Have major structural brain disease other than Alzheimer's Disease&#xD;
&#xD;
          -  Other severe acute or chronical medical or psychiatric condition or laboratory&#xD;
             abnormality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ATP Clinical Research, Inc</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Valley Research Center</name>
      <address>
        <city>Imperial</city>
        <state>California</state>
        <zip>92251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Valley Research</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RAA - Apex Aquisition, LLC</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geriatric and Adult Psychiatry LLC</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale-New Haven Hospital, Temple Radiology</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine, MRI Research Center (MRI)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Centers of America</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33437</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Laboratories</name>
      <address>
        <city>Deerfield Beach</city>
        <state>Florida</state>
        <zip>33064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research Inc</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research LLC-North Clinic</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Group of Central Florida</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Advanced Medical Research</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Research &amp; Wellness Institute, Inc.</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Charles Clinical Trials</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Imaging (Imaging only)</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Psychiatric Associates, LLC</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastside Comprehensive Medical Center, LLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center (MRI Imaging Only)</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Medical Research of Staten Island</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University (administrative offices only)</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University - 2050</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keystone Clinical Studies, LLC</name>
      <address>
        <city>Norristown</city>
        <state>Pennsylvania</state>
        <zip>19403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roper Hospital (Imaging Only)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roper St. Francis Healthcare</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roper St. Francis Pharmacy (IP Shipment/Storage)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Clinic, P.C.</name>
      <address>
        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Adults Speciality Research Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grayline Clinical Drug Trials</name>
      <address>
        <city>Wichita Falls</city>
        <state>Texas</state>
        <zip>76309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean Foundation for Health, Research and Education</name>
      <address>
        <city>Middleton</city>
        <state>Wisconsin</state>
        <zip>53562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cary J. Kohlenberg, MD, dba, IPC Research</name>
      <address>
        <city>Waukesha</city>
        <state>Wisconsin</state>
        <zip>53188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merrill Hills Manor</name>
      <address>
        <city>Waukesha</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>True North Clinical Research Halifax, Inc.</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3S 1M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatham-kent Clinical Trials Research Centre</name>
      <address>
        <city>Chatham</city>
        <state>Ontario</state>
        <zip>N7L 1C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatham-Kent Clinical Trials Research Centre</name>
      <address>
        <city>Chatham</city>
        <state>Ontario</state>
        <zip>N7M 5L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Recherches Neuro-Hippocampe Inc.</name>
      <address>
        <city>Gatineau</city>
        <state>Quebec</state>
        <zip>J8T 8J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psicomed Estudios Medicos CIA. LTDA</name>
      <address>
        <city>Antofagasta</city>
        <state>Ii Region</state>
        <zip>1270244</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biomedica Research Group</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>7500710</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Especialidades Medicas L Y S</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>7560356</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Espace Sante 2</name>
      <address>
        <city>La Seyne Sur Mer</city>
        <zip>83500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde</name>
      <address>
        <city>Berlin</city>
        <zip>10245</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum</name>
      <address>
        <city>Berlin</city>
        <zip>10365</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. sc. med. Alexander Schulze</name>
      <address>
        <city>Berlin</city>
        <zip>13156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arzneimittelforschung Leipzig Gmbh</name>
      <address>
        <city>Leipzig</city>
        <zip>04107</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs</name>
      <address>
        <city>Nuernberg</city>
        <zip>90402</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario De Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cantoblanco</name>
      <address>
        <city>Madrid</city>
        <zip>28049</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Institute for the Care of Older People Centre</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fulbourn Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB21 5EF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surrey and Borders Partnership NHS Foundation Trust</name>
      <address>
        <city>Chertsey</city>
        <zip>KT16 0AE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berrywood Hospital</name>
      <address>
        <city>Northampton</city>
        <zip>NN5 6UD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covance Laboratories</name>
      <address>
        <city>Switzerland</city>
        <zip>1217</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Chile</country>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
  </removed_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2081011&amp;StudyName=Study%20Evaluating%20TheSafety%20And%20Efficacy%20Of%20PF-05212377%20Or%20Placebo%20In%20Subjects%20With%20Alzheimer%27s%20Disease%20With%20Existing%20Neuropsychiatric%20Symp</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>August 26, 2016</results_first_submitted>
  <results_first_submitted_qc>January 30, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2017</results_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomized</keyword>
  <keyword>Double Blind</keyword>
  <keyword>Safety and Efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Before entering in the 12-week treatment period, participants were required to enter a 4-week placebo run-in period. 195 participants started the placebo run-in period, of which 186 were eligible for the treatment period. Among the 186 enrolled participants, 185 were treated with the double-blind study treatment, 1 was enrolled but not treated.</recruitment_details>
      <pre_assignment_details>This study was a multicenter Phase 2a, randomized, placebo controlled, safety and efficacy study of 18 weeks in duration in participants with mild-to-moderate Alzheimer's disease (AD) who were stable on treatment with 5 or 10 mg of donepezil and who had existing neuropsychiatric symptoms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Run-In</title>
          <description>Participants that received placebo during the 4-week single blind placebo run-in period</description>
        </group>
        <group group_id="P2">
          <title>PF-05212377 30 mg: Double Blind Period</title>
          <description>All participants that received PF-05212377 30 mg during the 12-week double blind period</description>
        </group>
        <group group_id="P3">
          <title>Placebo: Double Blind Period</title>
          <description>All participants that received placebo during the 12-week double blind period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo Run-in Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="195"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="185"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer willing to participate</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double Blind Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="91"/>
                <participants group_id="P3" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer willing to participate</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer met eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One (1) of participant randomized but not treated appeared under placebo run-in including his/her discontinued and safety information</population>
      <group_list>
        <group group_id="B1">
          <title>Not Randomized</title>
          <description>Participants who have been discontinued during the Placebo Run-In period</description>
        </group>
        <group group_id="B2">
          <title>PF-05212377 30 mg: Double Blind Period</title>
          <description>All participants entered the double blind period and received PF-05212377 30 mg</description>
        </group>
        <group group_id="B3">
          <title>Placebo: Double Blind Period</title>
          <description>All participants entered the double blind period and received placebo</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="94"/>
            <count group_id="B4" value="195"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.2" spread="8.8"/>
                    <measurement group_id="B2" value="76.0" spread="8.0"/>
                    <measurement group_id="B3" value="75.9" spread="7.5"/>
                    <measurement group_id="B4" value="76" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>FEMALE</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MALE</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in ADAS-cog13 Total Score at Week 16</title>
        <description>ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>The Full Analysis Set (FAS) is defined as all participants who were randomized. The FAS was the primary analysis set for efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants who received placebo contributing to the analysis during the double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ADAS-cog13 Total Score at Week 16</title>
          <description>ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.</description>
          <population>The Full Analysis Set (FAS) is defined as all participants who were randomized. The FAS was the primary analysis set for efficacy data.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.111" spread="0.6290"/>
                    <measurement group_id="O2" value="-0.584" spread="0.5995"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4256</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.695</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.8697</dispersion_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.424</ci_lower_limit>
            <ci_upper_limit>1.814</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)</title>
        <description>The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>The FAS is defined as all participants who are randomized. The FAS was the primary analysis set for efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants who received placebo contributing to the analysis during the double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)</title>
          <description>The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.</description>
          <population>The FAS is defined as all participants who are randomized. The FAS was the primary analysis set for efficacy data.</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.990" spread="1.2441"/>
                    <measurement group_id="O2" value="-6.184" spread="1.1801"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2027</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.194</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.7149</dispersion_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.013</ci_lower_limit>
            <ci_upper_limit>4.401</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation</title>
        <description>Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent</description>
        <time_frame>Week 4 to Week 18</time_frame>
        <population>All participants who received any treatment during double blind period</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation</title>
          <description>Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent</description>
          <population>All participants who received any treatment during double blind period</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period</title>
        <description>Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.&#xD;
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1).</description>
        <time_frame>Week 4 to Week 16</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing clinical laboratory data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period</title>
          <description>Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.&#xD;
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1).</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0"/>
                    <measurement group_id="O2" value="52.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)</title>
        <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants who received placebo with non-missing ECG data during the double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)</title>
          <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>milliseconds (msec)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" lower_limit="-52" upper_limit="24"/>
                    <measurement group_id="O2" value="-3.6" lower_limit="-82" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)</title>
        <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
        <time_frame>Baseline and Week 10</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)</title>
          <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-42" upper_limit="23"/>
                    <measurement group_id="O2" value="-1.3" lower_limit="-61" upper_limit="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)</title>
        <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
        <time_frame>Baseline and Week 16/Early Termination</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)</title>
          <description>The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" lower_limit="-69" upper_limit="24"/>
                    <measurement group_id="O2" value="-1.6" lower_limit="-49" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern</title>
        <description>Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value&gt;=300 msec , a PR increase of &gt;=25% (for participants with a baseline value&gt;=200 msec), or with an increase &gt;=50% (for participants with a baseline value&lt;200 msec) were counted.</description>
        <time_frame>Week 4 to Week 16</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern</title>
          <description>Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value&gt;=300 msec , a PR increase of &gt;=25% (for participants with a baseline value&gt;=200 msec), or with an increase &gt;=50% (for participants with a baseline value&lt;200 msec) were counted.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Baseline Maximum Absolute Value &gt;=300 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Baseline Maximum Increase &gt;=25/50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)</title>
        <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)</title>
          <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-22" upper_limit="43"/>
                    <measurement group_id="O2" value="-0.8" lower_limit="-14" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)</title>
        <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
        <time_frame>Baseline and Week 10</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)</title>
          <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-13" upper_limit="45"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-15" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)</title>
        <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
        <time_frame>Baseline and Week 16/Early Termination</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)</title>
          <description>The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-14" upper_limit="18"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-21" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern</title>
        <description>Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value&gt;=100 msec , a QRS complex increase of &gt;=25% (for participants with a baseline value&gt;=100 msec), or with an increase &gt;=50% (for participants with a baseline value&lt;100 msec) were counted.</description>
        <time_frame>Week 4 to Week 16</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern</title>
          <description>Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value&gt;=100 msec , a QRS complex increase of &gt;=25% (for participants with a baseline value&gt;=100 msec), or with an increase &gt;=50% (for participants with a baseline value&lt;100 msec) were counted.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Baseline Maximum Absolute Value &gt;=200 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Baseline Maximum Increase &gt;=25/50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)</title>
        <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)</title>
          <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" lower_limit="-31" upper_limit="37"/>
                    <measurement group_id="O2" value="-4.9" lower_limit="-35" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)</title>
        <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
        <time_frame>Baseline and Week 10</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)</title>
          <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-38" upper_limit="47"/>
                    <measurement group_id="O2" value="-5.5" lower_limit="-40" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)</title>
        <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
        <time_frame>Baseline and Week 16/Early Termination</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)</title>
          <description>The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="-31" upper_limit="34"/>
                    <measurement group_id="O2" value="-2.2" lower_limit="-62" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern</title>
        <description>Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.&#xD;
Participants with a post-baseline QTcF absolute value of 450 - &lt;480, 480 - &lt;500, or &gt;=500 mec, or with a post-baseline QTcF increase of 30 - &lt;60 or &gt;=60 msec were counted.</description>
        <time_frame>Week 4 to Week 16</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing ECG data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern</title>
          <description>Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.&#xD;
Participants with a post-baseline QTcF absolute value of 450 - &lt;480, 480 - &lt;500, or &gt;=500 mec, or with a post-baseline QTcF increase of 30 - &lt;60 or &gt;=60 msec were counted.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Baseline Absolute Value of 450-&lt;480 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                    <measurement group_id="O2" value="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Baseline Absolute Value of 480-&lt;500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline of 30 -&lt;60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline &gt;=60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)</title>
        <description>The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing vital signs data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)</title>
          <description>The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>millimeters of mercury (mm Hg)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" lower_limit="-38" upper_limit="19"/>
                    <measurement group_id="O2" value="-3.9" lower_limit="-52" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" lower_limit="-49" upper_limit="20"/>
                    <measurement group_id="O2" value="-3.0" lower_limit="-38" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" lower_limit="-37" upper_limit="26"/>
                    <measurement group_id="O2" value="-1.8" lower_limit="-33" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-23" upper_limit="17"/>
                    <measurement group_id="O2" value="-1.0" lower_limit="-23" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pulse Rate Changes From Baseline - Week 6 (Visit 3)</title>
        <description>The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing vital signs data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate Changes From Baseline - Week 6 (Visit 3)</title>
          <description>The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>beats per minute (bpm)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Pulse Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-30" upper_limit="30"/>
                    <measurement group_id="O2" value="1.4" lower_limit="-21" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Pulse Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-20" upper_limit="30"/>
                    <measurement group_id="O2" value="1.3" lower_limit="-12" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>BP Changes From Baseline - Week 10 (Visit 4)</title>
        <description>The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
        <time_frame>Baseline and Week 10</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing vital signs data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>BP Changes From Baseline - Week 10 (Visit 4)</title>
          <description>The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" lower_limit="-36" upper_limit="20"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-68" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" lower_limit="-33" upper_limit="32"/>
                    <measurement group_id="O2" value="0.8" lower_limit="-49" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" lower_limit="-32" upper_limit="20"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-39" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" lower_limit="-20" upper_limit="20"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-26" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pulse Rate Changes From Baseline - Week 10 (Visit 4)</title>
        <description>The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.</description>
        <time_frame>Baseline and Week 10</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing vital signs data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate Changes From Baseline - Week 10 (Visit 4)</title>
          <description>The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Pulse Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-26" upper_limit="22"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-24" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Pulse Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-20" upper_limit="24"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-19" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>BP Changes From Baseline - Week 16/Early Termination (Visit 5)</title>
        <description>The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
        <time_frame>Baseline and Week 16/Early Termination</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing vital signs data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>BP Changes From Baseline - Week 16/Early Termination (Visit 5)</title>
          <description>The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-30" upper_limit="27"/>
                    <measurement group_id="O2" value="-1.1" lower_limit="-30" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-30" upper_limit="32"/>
                    <measurement group_id="O2" value="-1.1" lower_limit="-26" upper_limit="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" lower_limit="-39" upper_limit="22"/>
                    <measurement group_id="O2" value="-0.3" lower_limit="-18" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-23" upper_limit="23"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-20" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)</title>
        <description>The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.</description>
        <time_frame>Baseline and Week 16/Early Termination</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo with non-missing vital signs data during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)</title>
          <description>The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Pulse Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-29" upper_limit="31"/>
                    <measurement group_id="O2" value="0.6" lower_limit="-22" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing Pulse Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-24" upper_limit="29"/>
                    <measurement group_id="O2" value="0.8" lower_limit="-17" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern</title>
        <description>Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.</description>
        <time_frame>Week 4 to Week 16</time_frame>
        <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>All participants receiving placebo during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern</title>
          <description>Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.</description>
          <population>All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absolute Supine Systolic BP&lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Standing Systolic BP&lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Supine Diastolic BP&lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Standing Diastolic BP &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Supine Pulse Rate &lt;40 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Supine Pulse Rate &gt;120 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Standing Pulse Rate &lt;40 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Standing Pulse Rate &gt;140 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in Supine Systolic BP&gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in Standing Systolic BP&gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in Supine Diastolic BP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in Standing Diastolic BP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in Supine Systolic BP&gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in Standing Systolic BP&gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in Supine Diastolic BP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in Standing Diastolic BP &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Participants in Each Category of C-CASA Mapped From the C-SSRS Responses</title>
        <description>Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.&#xD;
C-CASA Event Code: &lt;1&gt; Completed suicide; &lt;2&gt; Suicide attempt; &lt;3&gt; Preparatory acts towards imminent suicidal behavior; &lt;4&gt; Suicidal Ideation; &lt;7&gt; Self-injurious behavior, no suicidal intent.&#xD;
The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).&#xD;
Only participants falling any category of C-CASA events were listed below.</description>
        <time_frame>From Screening to Week 18/Early Termination</time_frame>
        <population>All participants screened and assigned</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Run-in</title>
            <description>All participants assigned to the placebo run-in period</description>
          </group>
          <group group_id="O2">
            <title>PF-05212377 30 mg</title>
            <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>All participants received placebo during double blind period</description>
          </group>
        </group_list>
        <measure>
          <title>Participants in Each Category of C-CASA Mapped From the C-SSRS Responses</title>
          <description>Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.&#xD;
C-CASA Event Code: &lt;1&gt; Completed suicide; &lt;2&gt; Suicide attempt; &lt;3&gt; Preparatory acts towards imminent suicidal behavior; &lt;4&gt; Suicidal Ideation; &lt;7&gt; Self-injurious behavior, no suicidal intent.&#xD;
The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).&#xD;
Only participants falling any category of C-CASA events were listed below.</description>
          <population>All participants screened and assigned</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (Visit 2): &lt;4&gt;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (Visit 3): &lt;4&gt;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (Visit 4): : &lt;4&gt;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16/Early Termination (Visit 5): &lt;4&gt;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (Visit 2): &lt;7&gt;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (Visit 3): &lt;7&gt;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through Week 18 (Visit 16)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Run-In</title>
          <description>Participants received placebo during the single blind placebo run-in period</description>
        </group>
        <group group_id="E2">
          <title>PF-05212377 30 mg</title>
          <description>participants who received PF-05212377 30 mg contributing to the analysis during double blind period</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>All participants receiving placebo during double blind period</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Accidental death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="195"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="91"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="195"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="91"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="195"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="195"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer</name_or_title>
      <organization>Pfizer</organization>
      <phone>1-8007181021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712074
org study id: B2081011
secondary id: 2014-000830-42
nct id: NCT01712074
lead sponsor: 
has dmc: Yes
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate
      Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil.
      The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered
      the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and
      neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor
      re-emergence of neuropsychiatric and cognitive symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in ADAS-cog13 Total Score at Week 16
time frame: Baseline and Week 16
description: ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
measure: Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)
time frame: Baseline and Week 16
description: The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
time frame: Week 4 to Week 18
description: Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent
measure: Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period
time frame: Week 4 to Week 16
description: Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1).
measure: Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)
time frame: Baseline and Week 6
description: The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).
measure: Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)
time frame: Baseline and Week 10
description: The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).
measure: Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)
time frame: Baseline and Week 16/Early Termination
description: The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).
measure: Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern
time frame: Week 4 to Week 16
description: Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value>=300 msec , a PR increase of >=25% (for participants with a baseline value>=200 msec), or with an increase >=50% (for participants with a baseline value<200 msec) were counted.
measure: Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)
time frame: Baseline and Week 6
description: The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.
measure: Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)
time frame: Baseline and Week 10
description: The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.
measure: Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)
time frame: Baseline and Week 16/Early Termination
description: The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.
measure: Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern
time frame: Week 4 to Week 16
description: Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value>=100 msec , a QRS complex increase of >=25% (for participants with a baseline value>=100 msec), or with an increase >=50% (for participants with a baseline value<100 msec) were counted.
measure: Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)
time frame: Baseline and Week 6
description: The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
measure: Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)
time frame: Baseline and Week 10
description: The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
measure: Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)
time frame: Baseline and Week 16/Early Termination
description: The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
measure: Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern
time frame: Week 4 to Week 16
description: Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.
Participants with a post-baseline QTcF absolute value of 450 - <480, 480 - <500, or >=500 mec, or with a post-baseline QTcF increase of 30 - <60 or >=60 msec were counted.
measure: Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)
time frame: Baseline and Week 6
description: The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.
measure: Pulse Rate Changes From Baseline - Week 6 (Visit 3)
time frame: Baseline and Week 6
description: The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.
measure: BP Changes From Baseline - Week 10 (Visit 4)
time frame: Baseline and Week 10
description: The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.
measure: Pulse Rate Changes From Baseline - Week 10 (Visit 4)
time frame: Baseline and Week 10
description: The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.
measure: BP Changes From Baseline - Week 16/Early Termination (Visit 5)
time frame: Baseline and Week 16/Early Termination
description: The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.
measure: Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)
time frame: Baseline and Week 16/Early Termination
description: The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.
measure: Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern
time frame: Week 4 to Week 16
description: Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.
measure: Participants in Each Category of C-CASA Mapped From the C-SSRS Responses
time frame: From Screening to Week 18/Early Termination
description: Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.
C-CASA Event Code: <1> Completed suicide; <2> Suicide attempt; <3> Preparatory acts towards imminent suicidal behavior; <4> Suicidal Ideation; <7> Self-injurious behavior, no suicidal intent.
The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).
Only participants falling any category of C-CASA events were listed below.
arm group label: 30 mg QD of PF-05212377
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-05212377 (SAM-760)
description: 30 mg QD of PF-05212377 (SAM-760)
arm group label: 30 mg QD of PF-05212377
intervention type: Other
intervention name: Placebo
description: Placebo QD
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Canada
country: Chile
country: France
country: Germany
country: Spain
country: United Kingdom
country: United States
country: Australia
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2081011&StudyName=Study%20Evaluating%20TheSafety%20And%20Efficacy%20Of%20PF-05212377%20Or%20Placebo%20In%20Subjects%20With%20Alzheimer%27s%20Disease%20With%20Existing%20Neuropsychiatric%20Symp
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Alzheimer Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 