Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00060476
Collaborator
(none)
15,000
23
Study Details
Study Description
Brief Summary
To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The duration of treatment is 6 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
15000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)
Actual Study Start Date
:
Jan 8, 2003
Actual Primary Completion Date
:
Dec 8, 2004
Actual Study Completion Date
:
Dec 8, 2004
Outcome Measures
Primary Outcome Measures
- Time to prostate cancer [Duration of Treatment]
Secondary Outcome Measures
- Time to aggressive prostate cancer [Duration of Treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Regular PSA testing and study biopsies required.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00060476
Other Study ID Numbers:
- 0966-201
- Formally-P30A03LD
- MK0966-201
- 2006_414
First Posted:
May 7, 2003
Last Update Posted:
May 9, 2017
Last Verified:
May 1, 2017