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

RECORDATI GROUP1,228 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,228

Conditions

Benign Prostatic Hyperplasia

Interventions

SilodosinDRUG

8 mg daily for 12 weeks

TamsulosinDRUG

0.4 mg daily for 12 weeks

PlaceboDRUG

once daily for 12 weeks

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, United Kingdom

Outcomes

Primary Outcomes

Change in baseline total score on the International Prostate Symptom Score

Time frame: 12 weeks

Secondary Outcomes

Change in baseline obstructive subscore of the International Prostate Symptom Score;

Time frame: 12 weeks

change in baseline irritative subscore of the International Prostate Symptom Score;

Time frame: 12 weeks

change in baseline maximum urine flow rate;

Time frame: 12 weeks

safety

Time frame: 52 weeks

Data from ClinicalTrials.gov

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