<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/NCT02972268</url>
  </required_header>
  <id_info>
    <org_study_id>JLP-1207-P3</org_study_id>
    <nct_id>NCT02972268</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH</brief_title>
  <official_title>Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeil Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jeil Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination&#xD;
      Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic&#xD;
      Hyperplasia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">August 14, 2018</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of TUFS</measure>
    <time_frame>12 weeks from baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change of total IPSS</measure>
    <time_frame>12 weeks from baseline</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">780</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tamsulosin 0.2mg + Solifenacin 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tamsulosin 0.2mg + Placebo(Solifenacin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin 0.2mg + Solifenacin 5mg</intervention_name>
    <description>Tamsulosin 0.2mg + Solifenacin 5mg for 12wks</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin 0.2mg + Placebo(Solifenacin)</intervention_name>
    <description>Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks</description>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 45 years&#xD;
&#xD;
          -  Benign Prostate Hyperplasia diagnosed by 20 mL &lt; TRUS&#xD;
&#xD;
          -  Lower urinary tract symptom suggestive of benign prostate hyperplasia, who&#xD;
             spontaneously agree to join and sign to the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have a history of the lower urinary tract cancer, including prostate&#xD;
             cancer and bladder cancer within the past 3 years&#xD;
&#xD;
          -  Subjects who have acute urinary retention within 12 weeks before screening&#xD;
&#xD;
          -  Subjects who have clinically significant severe cardiovascular disease(unstable&#xD;
             angina, myocardial infarction or arrhythmia) within 24 weeks before screening&#xD;
&#xD;
          -  Subjects who have hypersensitivity to investigational product&#xD;
&#xD;
          -  Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure,&#xD;
             bladder diverticulum&#xD;
&#xD;
          -  Subjects who have myasthenia gravis, narrow angle glaucoma&#xD;
&#xD;
          -  Subjects who have hereditary problems of galactose intolerance, Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption&#xD;
&#xD;
          -  SBP &gt; 180 mmHg or DBP &gt; 100 mmHg&#xD;
&#xD;
          -  HbA1c &gt; 9.0 %&#xD;
&#xD;
          -  Subjects who are judged by the investigators to be unsuitable to participate in the&#xD;
             clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myung Soo Choo, MD., Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
    <mesh_term>Solifenacin Succinate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972268
org study id: JLP-1207-P3
nct id: NCT02972268
lead sponsor: 
has dmc: No
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination
      Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic
      Hyperplasia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: change of TUFS
time frame: 12 weeks from baseline
measure: change of total IPSS
time frame: 12 weeks from baseline
arm group label: Group I
arm group type: Experimental
description: Tamsulosin 0.2mg + Solifenacin 5mg
arm group label: Group II
arm group type: Placebo Comparator
description: Tamsulosin 0.2mg + Placebo(Solifenacin)
intervention type: Drug
intervention name: Tamsulosin 0.2mg + Solifenacin 5mg
description: Tamsulosin 0.2mg + Solifenacin 5mg for 12wks
arm group label: Group I
intervention type: Drug
intervention name: Tamsulosin 0.2mg + Placebo(Solifenacin)
description: Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks
arm group label: Group II
criteria: 
gender: Male
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Myung Soo Choo, MD., Ph.D
role: Study Chair
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
mesh term: Tamsulosin
mesh term: Solifenacin Succinate
sharing ipd: No