The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

Watson Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Silodosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224133

SI04011

Details and patient eligibility

About

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Full description

This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.

All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Enrollment: 661 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, who have completed SI04009 or SI04010.

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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661 participants in 1 patient group

Silodosin

Experimental group

Description:

Silodosin 8 mg per day with food

Treatment:

Drug: Silodosin