Benign Prostatic Hyperplasia Clinical Trial
Verified date | August 2017 |
Source | Chong Kun Dang Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 455 |
Est. completion date | May 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Chong Kun Dang Pharmaceutical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score ) | From baseline at week 12 | ||
Secondary | 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 | From baseline at week 12 | |
Secondary | 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 | From baseline at week 8 |
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