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

Study Overview
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Brief Summary
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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
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin 0.2mg
* Drug: Tadalafil 5mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin 0.2mg+Tadalafil 5mg<br>Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d. | Drug: Tamsulosin 0.2mg<br>* per oral for 12weeks after 2 4weeks run-in period<br>Drug: Tadalafil 5mg<br>* per oral for 12weeks after 2 4weeks run-in period<br>|
| Active Comparator: Tamsulosin 0.2mg<br>Tamsulosin 0.2mg, po, q.d. | Drug: Tamsulosin 0.2mg<br>* per oral for 12weeks after 2 4weeks run-in period<br>|
| Active Comparator: Tadalafil 5mg<br>Tadalafil 5mg, po, q.d. | Drug: Tadalafil 5mg<br>* per oral for 12weeks after 2 4weeks run-in period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score ) |  | From baseline at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |