<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/NCT03246880</url>
  </required_header>
  <id_info>
    <org_study_id>150BPH15018</org_study_id>
    <nct_id>NCT03246880</nct_id>
  </id_info>
  <brief_title>Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <brief_summary>
    <textblock>
      A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III&#xD;
      Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia&#xD;
      Patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )</measure>
    <time_frame>From baseline at week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)</measure>
    <time_frame>From baseline at week 12</time_frame>
    <description>IPSS questionnaire(International Prostate Symptom Score ), IIEF-5(International Index of Erectile Function-5) questionnaire Change in score, ICIQ-MLUTS(International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean change of scores on IPSS ( International Prostate Symptom Score ), ICIQ-MLUTS( International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score</measure>
    <time_frame>From baseline at week 8</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">455</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Tamsulosin 0.2mg+Tadalafil 5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tamsulosin 0.2mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tamsulosin 0.2mg, po, q.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tadalafil 5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tadalafil 5mg, po, q.d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin 0.2mg</intervention_name>
    <description>per oral for 12weeks after 2~4weeks run-in period</description>
    <arm_group_label>Tamsulosin 0.2mg</arm_group_label>
    <arm_group_label>Tamsulosin 0.2mg+Tadalafil 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil 5mg</intervention_name>
    <description>per oral for 12weeks after 2~4weeks run-in period</description>
    <arm_group_label>Tadalafil 5mg</arm_group_label>
    <arm_group_label>Tamsulosin 0.2mg+Tadalafil 5mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        [Visit 1]&#xD;
&#xD;
          1. Male Aged of 45 or above&#xD;
&#xD;
          2. Patients must have a diagnosis of Benign Prostatic Hyperplasia&#xD;
&#xD;
          3. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13&#xD;
&#xD;
          4. Signed and dated informed consent document indicating that the patient&#xD;
&#xD;
        [Visit 2]&#xD;
&#xD;
          1. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13&#xD;
&#xD;
          2. 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml&#xD;
&#xD;
          3. PVR(post-void residual urine volume) ≤ 250ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months&#xD;
&#xD;
          2. Patients with prostate cancer or PSA &gt; 10ng/ml&#xD;
&#xD;
          3. Patients with other disease which could have influence on urine flow rate except&#xD;
             BPH(benign prostatic hyperplasia )&#xD;
&#xD;
          4. Patients with a history of operation on prostate which could have influence on the&#xD;
             result and need to have surgery.&#xD;
&#xD;
          5. Patients with acute urinary retention in 3months&#xD;
&#xD;
          6. Patients with a history of drug or alcohol abuse within 6 months&#xD;
&#xD;
          7. Patients have cardiovascular disease or associated disease which is not controlled.&#xD;
&#xD;
          8. Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor&#xD;
&#xD;
          9. Patients with orthostatic hypotension&#xD;
&#xD;
         10. Patients with a history micturition syncope&#xD;
&#xD;
         11. Patients with severe or malignant retinopathy&#xD;
&#xD;
         12. Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy&#xD;
&#xD;
         13. Patients with a congestive disease like galactose intolerance, Lapp lactase&#xD;
             deficiency, glucose-galactose malabsorption&#xD;
&#xD;
         14. Serum creatinine &gt; upper Normal Limit*2, AST/ALT &gt; upper Normal Limit*3&#xD;
&#xD;
         15. Patient with uncontrolled diabetes(HbA1C&gt;9%)&#xD;
&#xD;
         16. Patients have a history of malignant tumor within 5 years&#xD;
&#xD;
         17. Patients have hypersensitivity reaction on this drug.&#xD;
&#xD;
         18. Patients treated with other investigational product within 4 weeks at first time&#xD;
             taking the investigational product&#xD;
&#xD;
         19. Not eligible to participate for the study at the discretion of investigator&#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, M.D., Ph.D</last_name>
    <role>Principal Investigator</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 2017</verification_date>
  <study_first_submitted>September 2, 2015</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</mesh_term>
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246880
org study id: 150BPH15018
nct id: NCT03246880
lead sponsor: 
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III
      Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia
      Patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
time frame: From baseline at week 12
measure: The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)
time frame: From baseline at week 12
description: IPSS questionnaire(International Prostate Symptom Score ), IIEF-5(International Index of Erectile Function-5) questionnaire Change in score, ICIQ-MLUTS(International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score
measure: The mean change of scores on IPSS ( International Prostate Symptom Score ), ICIQ-MLUTS( International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score
time frame: From baseline at week 8
arm group label: Tamsulosin 0.2mg+Tadalafil 5mg
arm group type: Experimental
description: Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.
arm group label: Tamsulosin 0.2mg
arm group type: Active Comparator
description: Tamsulosin 0.2mg, po, q.d.
arm group label: Tadalafil 5mg
arm group type: Active Comparator
description: Tadalafil 5mg, po, q.d.
intervention type: Drug
intervention name: Tamsulosin 0.2mg
description: per oral for 12weeks after 2~4weeks run-in period
arm group label: Tamsulosin 0.2mg
arm group label: Tamsulosin 0.2mg+Tadalafil 5mg
intervention type: Drug
intervention name: Tadalafil 5mg
description: per oral for 12weeks after 2~4weeks run-in period
arm group label: Tadalafil 5mg
arm group label: Tamsulosin 0.2mg+Tadalafil 5mg
criteria: 
gender: Male
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Myung-Soo Choo, M.D., Ph.D
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tadalafil
mesh term: Tamsulosin