A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Overview
- Phase
- Phase 3
- Intervention
- Silodosin
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Sponsor
- Watson Pharmaceuticals
- Enrollment
- 461
- Primary Endpoint
- International Prostate Symptom Score (IPSS)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
Detailed Description
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
Investigators
Eligibility Criteria
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.
- •The use of concomitant drugs that would confound the efficacy evaluation.
- •The use of concomitant drugs that would be unsafe with this alpha-blocker.
Arms & Interventions
Silodosin
Silodosin 8 mg once daily with food
Intervention: Silodosin
placebo
Matching Placebo capsule once daily with food
Intervention: Placebo
Outcomes
Primary Outcomes
International Prostate Symptom Score (IPSS)
Time Frame: 12 weeks
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Secondary Outcomes
- Maximum Urine Flow Rate (Qmax)(12 weeks)