Benign Prostatic Hyperplasia
Conditions
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.
Interventions
DRUGTamsulosin 0.2mg
per oral for 12weeks after 2\ 4weeks run-in period
DRUGTadalafil 5mg
per oral for 12weeks after 2\ 4weeks run-in period
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score ) | From baseline at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume) | From baseline at week 12 | 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 | From baseline at week 8 | — |
Countries
South Korea
Outcome results
None listed