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A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00127179
First received: August 3, 2005
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.


Condition Intervention Phase
Benign Prostatic Hyperplasia
 Drug: MK0906, finasteride / Duration of Treatment: 48 weeks
Drug: Comparator: placebo / Duration of Treatment: 48 weeks
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Resource links provided by NLM:

Drug Information available for: Finasteride
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change from baseline in the International Prostate Symptom Score

Secondary Outcome Measures:
  • Change from baseline in QOL - index
  • Change from baseline in maximum urinary flow rate, %
  • Change from baseline in Prostate volume

Estimated Enrollment: 600
Study Start Date: January 2004
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with benign prostatic hyperplasia

Exclusion Criteria:

  • Patients who are suspected to be suffering from prostatic cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127179

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00127179     History of Changes
Other Study ID Numbers: 2005_042, MK0906-140
Study First Received: August 3, 2005
Last Updated: October 15, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013