The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia...
Date First Received: August 3, 2005
Last Updated: June 2, 2006
Verified by: Merck, September 2005
Clinical Trial Phase: Phase 3 | Start Date: January 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 600
Brief Summary
Official Title: “MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia”
Condition Keyword(s):
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0906, finasteride / Duration of Treatment: 48 weeks
- Drug: Comparator: placebo / Duration of Treatment: 48 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in the International Prostate Symptom Score
Secondary Measures
- Change from baseline in QOL - index
- Change from baseline in maximum urinary flow rate, %
- Change from baseline in Prostate volume
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with benign prostatic hyperplasia
Exclusion Criteria:
- Patients who are suspected to be suffering from prostatic cancer
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: 79 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00127179
Study ID Number: 2005_042
ClinicalTrials.gov Identifier: NCT00127179
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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