A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Watson Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Silodosin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224120

SI04010

Details and patient eligibility

About

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Full description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Enrollment: 462 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 BPH.

Exclusion criteria

• Medical conditions that would confound the efficacy evaluation.
• Medical conditions in which it would be unsafe to use an alpha-blocker.
• The use of concomitant drugs that would confound the efficacy evaluation.
• The 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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462 participants in 2 patient groups, including a placebo group

Silodosin

Experimental group

Description:

Silodosin 8 mg/Day with food

Treatment:

Drug: Silodosin

Placebo

Placebo Comparator group

Description:

Matching placebo capsule once daily with food

Treatment:

Other: Placebo