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Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin 0.2mg
Tadalafil 5mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

[Visit 1]

  1. Male Aged of 45 or above
  2. Patients must have a diagnosis of Benign Prostatic Hyperplasia
  3. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
  4. Signed and dated informed consent document indicating that the patient

[Visit 2]

  1. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
  2. 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
  3. PVR(post-void residual urine volume) ≤ 250ml

Exclusion Criteria:

  1. Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
  2. Patients with prostate cancer or PSA > 10ng/ml
  3. Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
  4. Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
  5. Patients with acute urinary retention in 3months
  6. Patients with a history of drug or alcohol abuse within 6 months
  7. Patients have cardiovascular disease or associated disease which is not controlled.
  8. Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor
  9. Patients with orthostatic hypotension
  10. Patients with a history micturition syncope
  11. Patients with severe or malignant retinopathy
  12. Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy
  13. Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  14. Serum creatinine > upper Normal Limit*2, AST/ALT > upper Normal Limit*3
  15. Patient with uncontrolled diabetes(HbA1C>9%)
  16. Patients have a history of malignant tumor within 5 years
  17. Patients have hypersensitivity reaction on this drug.
  18. Patients treated with other investigational product within 4 weeks at first time taking the investigational product
  19. Not eligible to participate for the study at the discretion of investigator

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Tamsulosin 0.2mg+Tadalafil 5mg

Tamsulosin 0.2mg

Tadalafil 5mg

Arm Description

Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.

Tamsulosin 0.2mg, po, q.d.

Tadalafil 5mg, po, q.d.

Outcomes

Primary Outcome Measures

The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )

Secondary Outcome Measures

The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)
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
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

Full Information

First Posted
September 2, 2015
Last Updated
August 8, 2017
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03246880
Brief Title
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
455 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin 0.2mg+Tadalafil 5mg
Arm Type
Experimental
Arm Description
Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.
Arm Title
Tamsulosin 0.2mg
Arm Type
Active Comparator
Arm Description
Tamsulosin 0.2mg, po, q.d.
Arm Title
Tadalafil 5mg
Arm Type
Active Comparator
Arm Description
Tadalafil 5mg, po, q.d.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin 0.2mg
Intervention Description
per oral for 12weeks after 2~4weeks run-in period
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg
Intervention Description
per oral for 12weeks after 2~4weeks run-in period
Primary Outcome Measure Information:
Title
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
Time Frame
From baseline at week 12
Secondary Outcome Measure Information:
Title
The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)
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
Time Frame
From baseline at week 12
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: [Visit 1] Male Aged of 45 or above Patients must have a diagnosis of Benign Prostatic Hyperplasia IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13 Signed and dated informed consent document indicating that the patient [Visit 2] IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml PVR(post-void residual urine volume) ≤ 250ml Exclusion Criteria: Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months Patients with prostate cancer or PSA > 10ng/ml Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia ) Patients with a history of operation on prostate which could have influence on the result and need to have surgery. Patients with acute urinary retention in 3months Patients with a history of drug or alcohol abuse within 6 months Patients have cardiovascular disease or associated disease which is not controlled. Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor Patients with orthostatic hypotension Patients with a history micturition syncope Patients with severe or malignant retinopathy Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Serum creatinine > upper Normal Limit*2, AST/ALT > upper Normal Limit*3 Patient with uncontrolled diabetes(HbA1C>9%) Patients have a history of malignant tumor within 5 years Patients have hypersensitivity reaction on this drug. Patients treated with other investigational product within 4 weeks at first time taking the investigational product Not eligible to participate for the study at the discretion of investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung-Soo Choo, M.D., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

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