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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg

• Registration Number: NCT03246880
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-02
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-08
• Last Update Submitted: 2017-08-08
• Study First Posted: 2017-08-11
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 455

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin 0.2mg+Tadalafil 5mg	Tamsulosin 0.2mg	Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.
Tamsulosin 0.2mg+Tadalafil 5mg	Tadalafil 5mg	Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.
Tamsulosin 0.2mg	Tamsulosin 0.2mg	Tamsulosin 0.2mg, po, q.d.
Tadalafil 5mg	Tadalafil 5mg	Tadalafil 5mg, po, q.d.

Primary Outcome Measures

Name	Time	Method
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )	From baseline at week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of