A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)
Phase 3
50 Years
75 Years
50 Years
75 Years
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)
The duration of treatment is 6 years.
Inclusion Criteria
Regular PSA testing and study biopsies required.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Time to prostate cancer
Outcome Time Frame:
Duration of Treatment
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_414
NCT ID:
NCT00060476
Start Date:
June 2003
Completion Date:
February 2005
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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