<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/NCT01673490</url>
  </required_header>
  <id_info>
    <org_study_id>114785</org_study_id>
    <nct_id>NCT01673490</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia</brief_title>
  <acronym>FDC114785</acronym>
  <official_title>A Pivotal, Open-label Trial Assessing the Safety and Efficacy of the 0.5 mg Dutasteride and 0.4 mg Tamsulosin Combination Once Daily for Six Months in Patients With Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90&#xD;
      subjects will be enrolled so that among them at least 57 will complete the 6-month treatment&#xD;
      period and evaluable for analysis.&#xD;
&#xD;
      -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination&#xD;
      therapy for six month in BPH patients by monitoring category, frequency and severity of&#xD;
      adverse events encountered during the treatment period.&#xD;
&#xD;
      -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin&#xD;
      combination therapy with regard to symptom improvement in BPH patients by monitoring and&#xD;
      analyzing of changes in IPSS and Qmax after 6 months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF collection,&#xD;
      subject code assignment, physical examination (vital signs, demographic data, medical&#xD;
      history); checking of inclusion and exclusion criteria: prostate symptom score according to&#xD;
      IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA level,&#xD;
      free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography (TRUS),&#xD;
      12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ),&#xD;
      concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3):&#xD;
      Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG,&#xD;
      adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of&#xD;
      dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be&#xD;
      recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and&#xD;
      collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following&#xD;
      items will be recorded: vital signs, laboratory tests (hematology, blood chemistry,&#xD;
      electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ&#xD;
      score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP&#xD;
      doses. • Visit 4 (Month 4.5 (M4) - D135 ± 3): Following items will be recorded: treatment&#xD;
      compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and&#xD;
      collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following&#xD;
      items will be recorded: treatment compliance, vital signs, prostate symptom score according&#xD;
      to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis,&#xD;
      12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ&#xD;
      score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month&#xD;
      7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The sole investigative site refused to accept the amended protocol and declined to continue the&#xD;
    study. There was no safety signal nor any other reason.&#xD;
  </why_stopped>
  <start_date type="Actual">June 29, 2012</start_date>
  <completion_date type="Actual">March 20, 2015</completion_date>
  <primary_completion_date type="Actual">March 20, 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs</measure>
    <time_frame>From start of study medication until follow-up (up to 7 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs</measure>
    <time_frame>From start of study medication until follow-up (up to 7 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points</measure>
    <time_frame>Screening, Month 1, Month 3 and Month 6</time_frame>
    <description>A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline</measure>
    <time_frame>Screening, Month 1, Month 3 and Month 6</time_frame>
    <description>Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline</measure>
    <time_frame>Screening, Month 3 and Month 6</time_frame>
    <description>Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number Participants With a Negative or Positive Response at the Indicated Time Points</measure>
    <time_frame>Screening, Month 3 and Month 6</time_frame>
    <description>Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points</measure>
    <time_frame>Baseline, Month 3 and Month 6</time_frame>
    <description>Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Free to Total PSA Ratio at the Indicated Time Points</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points</measure>
    <time_frame>Baseline, Month 3 and Month 6</time_frame>
    <description>The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Combodart/Duodart</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dutasteride/Tamsulosin</intervention_name>
    <description>0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment</description>
    <arm_group_label>Combodart/Duodart</arm_group_label>
    <other_name>Duodart</other_name>
    <other_name>combodart</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male, age ≥ 50 years. Clinical diagnosis of benign prostate hypertrophy (BPH) .&#xD;
        International Prostate Symptom Score (IPSS) ≥ 12 Prostate volume ≥30 ml (transrectal&#xD;
        ultrasonography). Total serum prostate specific antigen (PSA) ≥1.5 ng/mL and ≤10 ng/mL.&#xD;
        Free-to-total PSA ratio &gt; 20% Maximum flow rate (Qmax) &gt;5 mL/sec and ≤15 mL/sec and&#xD;
        post-void residual volume of &lt; 150 mL Willing and able to give written informed consent and&#xD;
        comply with study procedures throughout study Able to swallow and retain oral medication&#xD;
        Able to express personal thought and feeling Ability to read and comprehend information on&#xD;
        the Sexual Function Inventory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious&#xD;
        digital rectal examination).&#xD;
&#xD;
        Previous prostatic surgery (TURP, balloon dilatation, thermotherapy and stent replacement)&#xD;
        or other invasive procedures to treat BPH.&#xD;
&#xD;
        History of flexible/rigid cystoscopy or other instrumentation of the urethra within past 7&#xD;
        days History of acute urine retention (AUR) within past 3 months. Any causes other than BPH&#xD;
        result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck&#xD;
        contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or&#xD;
        chronic urinary tract infections).&#xD;
&#xD;
        History of breast cancer or clinical finding suggestive of malignancy. Use of any&#xD;
        5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®), drugs with antiandrogenic&#xD;
        properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole,&#xD;
        progestational agents), drugs which induce gynecomastia or drugs which affect prostate&#xD;
        volume, within past 6 months and throughout the study (other than as study medication). Do&#xD;
        not use dutasteride within past 12 months. Do not use metronidazole for a long time.&#xD;
&#xD;
        Concurrent use of anabolic steroids (eg. Durabolin®). Use of phytotherapy (eg: Tadenan®,&#xD;
        Permixon®, etc) for BPH within 2 weeks of screening visit and/or predicted to need&#xD;
        phytotherapy during the study.&#xD;
&#xD;
        Use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin,&#xD;
        alfuzosin and doxazosin) within 2 weeks of screening visit and/or predicted to need any&#xD;
        alpha blockers other than tamsulosin during the study.&#xD;
&#xD;
        Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine)&#xD;
        or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol&#xD;
        chloride) within 48 hours prior to all uroflowmetry assessments.&#xD;
&#xD;
        Hypersensitivity to any alpha-/beta-adrenoreceptor blocker or 5-alpha-reductase inhibitor,&#xD;
        or other chemically-related drugs.&#xD;
&#xD;
        Concurrent use of drugs known or thought to have an interaction with tamsulosin and&#xD;
        dutasteride.&#xD;
&#xD;
        History of hepatic impairment or abnormal liver function tests at screening (defined ALT,&#xD;
        AST, and/or alkaline phosphatase &gt;2 times the upper limit of normal, or total bilirubin&#xD;
        &gt;1.5 times the upper limit of normal).&#xD;
&#xD;
        History of renal insufficiency, or serum creatinine &gt;1.5 times the upper limit of normal at&#xD;
        screening.&#xD;
&#xD;
        History of malignancies other than basal cell carcinoma or squamous cell carcinoma of the&#xD;
        skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of&#xD;
        disease for at least 5 years prior to screening are eligible.&#xD;
&#xD;
        Any unstable, serious co-existing medical condition(s) including, but not limited to,&#xD;
        myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,&#xD;
        clinically evident congestive heart failure, or cerebrovascular accident within past 6&#xD;
        months; medically uncontrollable diabetes or peptic ulcer disease History of postural&#xD;
        hypotension, dizziness, vertigo or any signs and symptoms of orthostasis, which in&#xD;
        judgments of investigator, could be exacerbated by tamsulosin History of unsuccessful&#xD;
        treatment with tamsulosin or 'first dose' hypotensive episode on initiation of&#xD;
        alpha-1-adrenoreceptor antagonist therapy.&#xD;
&#xD;
        History of unsuccessful treatment with finasteride or dutasteride. Willing to have a child&#xD;
        during the treatment period or within 6 months thereafter Having female partner who is a&#xD;
        pregnant woman or in child-bearing age and refuse to use condom for sexual protection&#xD;
        Willing to donate blood during treatment period or within 6 months thereafter. History or&#xD;
        current evidence of drug or alcohol abuse within past 12 months. History of any illness&#xD;
        might confound the results of the study or poses additional risk to the patient.&#xD;
&#xD;
        Participation in investigational or marketed drug trial within 30 days preceding the&#xD;
        screening visit and/or during the study treatment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ho Chi Minh</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <link>
    <url>https://clinicalstudydatarequest.com</url>
    <description>IPD for this study will be made available via the Clinical Study Data Request site.</description>
  </link>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>June 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>October 8, 2015</results_first_submitted>
  <results_first_submitted_qc>November 16, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 17, 2015</results_first_posted>
  <last_update_submitted>July 20, 2018</last_update_submitted>
  <last_update_submitted_qc>July 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benign Prostatic Hyperplasia</keyword>
  <keyword>dutasteride and tamsulosin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
    <mesh_term>Dutasteride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Eligible participants with benign prostatic hyperplasia (BPH) entered into a 6-month enrollment period followed by a6-month treatment period and a one-month follow-up period. The total duration of the study was 13 months.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
          <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
          <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
          </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="66.5" spread="8.37"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs</title>
        <description>An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.</description>
        <time_frame>From start of study medication until follow-up (up to 7 months)</time_frame>
        <population>Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs</title>
          <description>An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.</description>
          <population>Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any treatment-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs</title>
        <description>An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.</description>
        <time_frame>From start of study medication until follow-up (up to 7 months)</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs</title>
          <description>An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any treatment-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points</title>
        <description>A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).</description>
        <time_frame>Screening, Month 1, Month 3 and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points</title>
          <description>A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1, n=56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, n=53</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline</title>
        <description>Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.</description>
        <time_frame>Screening, Month 1, Month 3 and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline</title>
          <description>Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT, n=48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, n=49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, n=51</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, n=47</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, n=56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, n=53</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline</title>
        <description>Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.</description>
        <time_frame>Screening, Month 3 and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline</title>
          <description>Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils/Leukocytes, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils/Leukocytes, n=46</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery Mean Corpuscular HGB Concentration, n=44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery Mean Corpuscular Hemoglobin, n=36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery Mean Corpuscular Volume, n=42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, n=49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes Distribution Width, n=4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, n=48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, n=49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, n=47</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes, n=53</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes/Leukocytes, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes, n=41</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, n=53</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number Participants With a Negative or Positive Response at the Indicated Time Points</title>
        <description>Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.</description>
        <time_frame>Screening, Month 3 and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number Participants With a Negative or Positive Response at the Indicated Time Points</title>
          <description>Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythrocytes, SC, POS, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, SC, NEG, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, 3M, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, 3M, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, 6M, POS, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, 6M, NEG, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, FV, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, FV, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, SC, POS, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, SC, NEG, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, 3M, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, 3M, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, 6M, POS, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, 6M, NEG, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, FV, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, FV, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, SC, POS, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, SC, NEG, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, 3M, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, 3M, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, 6M, POS, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, 6M, NEG, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, FV, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketones, FV, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, SC, POS, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, SC, NEG, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, 3M, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, 3M, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, 6M, POS, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, 6M, NEG, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, FV, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, FV, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, SC, POS, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, SC, NEG, n=59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, 3M, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, 3M, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, 6M, POS, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, 6M, NEG, N=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, FV, POS, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, FV, NEG, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points</title>
        <description>Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.</description>
        <time_frame>Baseline, Month 3 and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points</title>
          <description>Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Microgram per liter (ug/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.499" spread="1.2263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.824" spread="1.2413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Free to Total PSA Ratio at the Indicated Time Points</title>
        <description>Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Free to Total PSA Ratio at the Indicated Time Points</title>
          <description>Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, n=50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.207" spread="10.5868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.887" spread="8.1112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6</title>
        <description>The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6</title>
          <description>The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="3.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points</title>
        <description>The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.</description>
        <time_frame>Baseline, Month 3 and Month 6</time_frame>
        <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
            <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points</title>
          <description>The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.</description>
          <population>ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.</population>
          <units>Mililiter/seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3, n=54</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.77" spread="4.361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" spread="3.684"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>for Month 3</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>for Month 6</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to Month 7).</time_frame>
      <desc>SAEs and non-serious AEs were collected for the participants of the ITT population, comprised of all enrolled participants regardless of whether or not study treatment was administered.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg</title>
          <description>Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>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="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT01673490
org study id: 114785
nct id: NCT01673490
lead sponsor: 
has dmc: No
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90
      subjects will be enrolled so that among them at least 57 will complete the 6-month treatment
      period and evaluable for analysis.

      -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination
      therapy for six month in BPH patients by monitoring category, frequency and severity of
      adverse events encountered during the treatment period.

      -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin
      combination therapy with regard to symptom improvement in BPH patients by monitoring and
      analyzing of changes in IPSS and Qmax after 6 months of treatment.
Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF collection,
      subject code assignment, physical examination (vital signs, demographic data, medical
      history); checking of inclusion and exclusion criteria: prostate symptom score according to
      IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA level,
      free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography (TRUS),
      12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ),
      concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3):
      Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG,
      adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of
      dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be
      recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and
      collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following
      items will be recorded: vital signs, laboratory tests (hematology, blood chemistry,
      electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ
      score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP
      doses. • Visit 4 (Month 4.5 (M4) - D135 ± 3): Following items will be recorded: treatment
      compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and
      collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following
      items will be recorded: treatment compliance, vital signs, prostate symptom score according
      to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis,
      12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ
      score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month
      7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
time frame: From start of study medication until follow-up (up to 7 months)
description: An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
measure: Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
time frame: From start of study medication until follow-up (up to 7 months)
description: An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
time frame: Screening, Month 1, Month 3 and Month 6
description: A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).
measure: Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
time frame: Screening, Month 1, Month 3 and Month 6
description: Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.
measure: Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
time frame: Screening, Month 3 and Month 6
description: Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.
measure: Number Participants With a Negative or Positive Response at the Indicated Time Points
time frame: Screening, Month 3 and Month 6
description: Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.
measure: Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
time frame: Baseline, Month 3 and Month 6
description: Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.
measure: Free to Total PSA Ratio at the Indicated Time Points
time frame: Baseline, Month 6
description: Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.
measure: Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6
time frame: Baseline and Month 6
description: The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.
measure: Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
time frame: Baseline, Month 3 and Month 6
description: The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.
arm group label: Combodart/Duodart
arm group type: Experimental
description: Single arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin
intervention type: Drug
intervention name: Dutasteride/Tamsulosin
description: 0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment
arm group label: Combodart/Duodart
other name: Duodart
other name: combodart
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: Vietnam
url: https://clinicalstudydatarequest.com
description: IPD for this study will be made available via the Clinical Study Data Request site.
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tamsulosin
mesh term: Dutasteride
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 