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

NCT ID: NCT03246880

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 455 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tamsulosin 0.2mg+Tadalafil 5mg

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

Group Type: EXPERIMENTAL

Tamsulosin 0.2mg

Intervention Type: DRUG

per oral for 12weeks after 2\~4weeks run-in period

Tadalafil 5mg

Intervention Type: DRUG

per oral for 12weeks after 2\~4weeks run-in period

Tamsulosin 0.2mg

Tamsulosin 0.2mg, po, q.d.

Group Type: ACTIVE_COMPARATOR

Tamsulosin 0.2mg

Intervention Type: DRUG

per oral for 12weeks after 2\~4weeks run-in period

Tadalafil 5mg

Tadalafil 5mg, po, q.d.

Group Type: ACTIVE_COMPARATOR

Tadalafil 5mg

Intervention Type: DRUG

per oral for 12weeks after 2\~4weeks run-in period

Interventions

Tamsulosin 0.2mg

per oral for 12weeks after 2\~4weeks run-in period

Intervention Type: DRUG

Tadalafil 5mg

per oral for 12weeks after 2\~4weeks run-in period

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung-Soo Choo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

150BPH15018

Identifier Type: -

Identifier Source: org_study_id