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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359905
• Other study ID #: KMD3213-IT-CL 0215
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2006
• Last updated: February 18, 2009
• Start date: May 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2009
• Source: Recordati Industria Chimica e Farmaceutica S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1228
• Est. completion date: January 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

• Use of concomitant drugs that would confound the efficacy evaluation

• Use of concomitant drugs that would be unsafe with this alpha-blocker

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Signs and Symptoms

Intervention

Drug:
• Silodosin
8 mg daily for 12 weeks
• Tamsulosin
0.4 mg daily for 12 weeks
• Placebo
once daily for 12 weeks

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Recordati Industria Chimica e Farmaceutica S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline total score on the International Prostate Symptom Score		12 weeks	No
Secondary	Change in baseline obstructive subscore of the International Prostate Symptom Score;		12 weeks	No
Secondary	change in baseline irritative subscore of the International Prostate Symptom Score;		12 weeks	No
Secondary	change in baseline maximum urine flow rate;		12 weeks	No
Secondary	safety		52 weeks	Yes