NCT00359905

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,228 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Silodosin	8 mg daily for 12 weeks
DRUG	Tamsulosin	0.4 mg daily for 12 weeks
DRUG	Placebo	once daily for 12 weeks

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• Completion: 2008-01-01
• First posted: 2006-08-03
• Last updated: 2009-02-19

Locations

1 site across 1 country: United Kingdom