NCT00224133

The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

A Multi-Center, Open-Label Evaluation of the 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: 661 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Detailed description

This will be a multi-center, open-label 40 week investigation in up to 1,200 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, adverse events, concomitant medications, and compliance. All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Silodosin	8 mg daily

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-09-22
• Last updated: 2010-04-27
• Results posted: 2010-04-27

Locations

79 sites across 1 country: United States