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

NCT00224107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2011-07-12

Study results available
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Summary

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.

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DRUG

Silodosin

8 mg daily for 12 weeks

OTHER

Placebo

1 capsule daily for 12 weeks

Sponsors & Collaborators

  • Watson Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lawrence Hill, PharmD, RPh · Watson Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00224107 on ClinicalTrials.gov