<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/NCT03776058</url>
  </required_header>
  <id_info>
    <org_study_id>00990160</org_study_id>
    <nct_id>NCT03776058</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Clinical Effects of Twice-daily Doses of an Oral Calcimimetic Agent (AMG 073) in Subjects With Primary Hyperparathyroidism (HPT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives were to assess the safety and tolerability of twice daily (BID) doses&#xD;
      of 65 mg cinacalcet administered orally to adults with primary HPT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2000</start_date>
  <completion_date type="Actual">December 26, 2000</completion_date>
  <primary_completion_date type="Actual">December 26, 2000</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Serum Calcium</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in 1,25 dihydroxy Vitamin D3</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Serum Phosphorus</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in N-telopeptide (NTx)</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Urine Osmolality</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Calcium/Creatinine Ratio</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Phosphorus/Creatinine Ratio</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in N-telopeptide/Creatinine Ratio</measure>
    <time_frame>Baseline and week 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Primary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Cinacalcet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 65 mg cinacalcet orally twice a day for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo to cinacalcet orally twice a day for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cinacalcet</intervention_name>
    <description>Tablets for oral administration</description>
    <arm_group_label>Cinacalcet</arm_group_label>
    <other_name>AMG 073</other_name>
    <other_name>Sensipar®</other_name>
    <other_name>Mimpara®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets for oral administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women ≥ 18 years old before beginning of screening&#xD;
&#xD;
          -  Use, in the opinion of the principal investigator, effective contraceptive measures&#xD;
             throughout the study&#xD;
&#xD;
          -  Negative serum pregnancy test within 15 days before day 0&#xD;
&#xD;
          -  Plasma iPTH concentration &gt; 45 pg/mL on at least 2 occasions (during the screening&#xD;
             phase) at least 7 days apart&#xD;
&#xD;
          -  Serum calcium concentration ≥ 11 mg/dL on 2 occasions (during the screening phase) at&#xD;
             least 7 days apart&#xD;
&#xD;
          -  Acceptable renal function, with an estimated creatinine clearance &gt; 50 mL/min as&#xD;
             determined by the Cockroft and Gault equation&#xD;
&#xD;
          -  Acceptable hepatic function, defined as serum aspartate transaminase (AST), alanine&#xD;
             transaminase (ALT), and total bilirubin ≤ 2 times the upper limit of normal (central&#xD;
             laboratory's range)&#xD;
&#xD;
          -  Laboratory test results within the central laboratory's normal range for hematology,&#xD;
             coagulation, urinalysis, and clinical chemistry parameters not mentioned specifically&#xD;
             in other inclusion/exclusion criteria&#xD;
&#xD;
          -  Chest x-ray within the past 12 months, with no evidence of an active infectious,&#xD;
             inflammatory, or malignant process&#xD;
&#xD;
          -  Informed consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any unstable medical condition requiring hospitalization within 30 days before day 0,&#xD;
             or otherwise unstable condition in the judgment of the investigator&#xD;
&#xD;
          -  Awaiting or scheduled for parathyroidectomy within 2 months after study day 0&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Received, within 21 days before day 0, therapy with systemic glucocorticoids (&gt; 5&#xD;
             mg/day prednisone or equivalent), lithium, tricyclic antidepressants (with the&#xD;
             exception of amitriptyline and nortriptyline), thioridazine, haloperidol, flecainide,&#xD;
             drugs with a narrow therapeutic index that are primarily metabolized by hepatic&#xD;
             cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (ie,&#xD;
             thiazide or loop diuretics), or calcitonin&#xD;
&#xD;
          -  Dose changes in bisphosphonates, thyroid replacement therapy, selective estrogen&#xD;
             receptor modulators (SERMs), or changes in daily doses of estrogen (greater than 0.75&#xD;
             mg) within 90 days before day 0&#xD;
&#xD;
          -  Subjects who discontinued estrogen or SERM therapy must have been off treatment for at&#xD;
             least 90 days before day 0.&#xD;
&#xD;
          -  Alcohol or illicit drug abuse within 12 months before day 0 based on self-report&#xD;
&#xD;
          -  Myocardial infarction within 6 months before day 0&#xD;
&#xD;
          -  Ventricular rhythm disturbance requiring current treatment&#xD;
&#xD;
          -  Seizure within 12 months before day 0&#xD;
&#xD;
          -  History (within 5 years) of malignancy of any type, other than nonmelanomatous skin&#xD;
             cancers or in situ cervical cancer&#xD;
&#xD;
          -  Evidence (within 5 years) of treatment for and/or active sarcoidosis, tuberculosis, or&#xD;
             diseases other than primary HPT known to cause hypercalcemia&#xD;
&#xD;
          -  History of familial hypocalciuric hypercalcemia (FHH)&#xD;
&#xD;
          -  Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0&#xD;
&#xD;
          -  Gastrointestinal disorder that may be associated with impaired absorption of orally&#xD;
             administered medications&#xD;
&#xD;
          -  Inability to swallow tablets similar in size to an aspirin tablet&#xD;
&#xD;
          -  Known sensitivity to products administered during the study&#xD;
&#xD;
          -  Previous participation as a subject in this study (ie, withdrawn early) or a prior&#xD;
             study involving AMG 073 administration&#xD;
&#xD;
          -  Enrolled in, or not yet completed at least 28 days since ending other investigational&#xD;
             device or drug trial(s)&#xD;
&#xD;
          -  Psychiatric disorder that would interfere with understanding and giving informed&#xD;
             consent or compliance with protocol requirements&#xD;
&#xD;
          -  Any other condition that might reduce the chance of obtaining data (ie, known poor&#xD;
             compliance) required by the protocol or that might compromise the ability to give&#xD;
             truly informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Primary</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cinacalcet</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03776058
org study id: 00990160
nct id: NCT03776058
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objectives were to assess the safety and tolerability of twice daily (BID) doses
      of 65 mg cinacalcet administered orally to adults with primary HPT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants with Adverse Events
time frame: 4 weeks
measure: Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments
time frame: 4 weeks
measure: Percent Change from Baseline in Serum Calcium
time frame: Baseline and week 4
measure: Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)
time frame: Baseline and week 4
measure: Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)
time frame: Baseline and week 4
measure: Percent Change from Baseline in 1,25 dihydroxy Vitamin D3
time frame: Baseline and week 4
measure: Percent Change from Baseline in Serum Phosphorus
time frame: Baseline and week 4
measure: Percent Change from Baseline in N-telopeptide (NTx)
time frame: Baseline and week 4
measure: Percent Change from Baseline in Urine Osmolality
time frame: Baseline and week 4
measure: Percent Change from Baseline in Calcium/Creatinine Ratio
time frame: Baseline and week 4
measure: Percent Change from Baseline in Phosphorus/Creatinine Ratio
time frame: Baseline and week 4
measure: Percent Change from Baseline in N-telopeptide/Creatinine Ratio
time frame: Baseline and week 4
arm group label: Cinacalcet
arm group type: Experimental
description: Participants received 65 mg cinacalcet orally twice a day for 4 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo to cinacalcet orally twice a day for 4 weeks.
intervention type: Drug
intervention name: Cinacalcet
description: Tablets for oral administration
arm group label: Cinacalcet
other name: AMG 073
other name: Sensipar®
other name: Mimpara®
intervention type: Drug
intervention name: Placebo
description: Tablets for oral administration
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Primary
mesh term: Cinacalcet