NCT00224107

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DRUG	Silodosin	8 mg daily for 12 weeks
OTHER	Placebo	1 capsule daily for 12 weeks

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-22
• Last updated: 2011-07-12
• Results posted: 2009-12-03

Locations

43 sites across 1 country: United States