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

Recordati

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Silodosin; Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359905

KMD3213-IT-CL 0215

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,228 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,228 participants in 3 patient groups, including a placebo group

Silodosin

Experimental group

Treatment:

Drug: Silodosin

Tamsulosin

Active Comparator group

Treatment:

Drug: Tamsulosin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo