Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

Study Overview
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Brief Summary
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A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.

Detailed Description
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This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved

Official Title
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Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Silodosin
* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia Exclusion Criteria: Medical conditions that would confound the efficacy evaluation Medical conditions in which it would be unsafe to use an alpha-blocker Use of concomitant drugs that would confound the efficacy evaluation Use of concomitant drugs that would be unsafe with this alpha-blocker

Ages Eligible for Study
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Minimum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silodosin<br> | Drug: Silodosin<br>* 8 mg daily for 12 weeks<br>* Other names: KMD3213;|
| Active Comparator: Tamsulosin<br> | Drug: Tamsulosin<br>* 0.4 mg daily for 12 weeks<br>* Other names: Omnic;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline total score on the International Prostate Symptom Score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline obstructive subscore of the International Prostate Symptom Score; |  | 12 weeks | 
| change in baseline irritative subscore of the International Prostate Symptom Score; |  | 12 weeks | 
| change in baseline maximum urine flow rate; |  | 12 weeks | 
| safety |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, alpha-blockers