Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign prostatic hyperplasia, BPH, alpha blocker
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 461
Healthy volunteers: no

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.

Arms:
arm 1: Silodosin 8 mg once daily with food arm 2: Matching Placebo capsule once daily with food

Interventions: intervention 1: Silodosin intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg daily for 12 weeks intervention 2: 1 capsule daily for 12 weeks

Protocol document: