Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00060476
First received: May 6, 2003
Last updated: September 15, 2015
Last verified: September 2015

May 6, 2003
September 15, 2015
January 2003
December 2004   (final data collection date for primary outcome measure)
Time to prostate cancer [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00060476 on ClinicalTrials.gov Archive Site
Time to aggressive prostate cancer [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]
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Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)
To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.
The duration of treatment is 6 years.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Prostate Cancer
  • Drug: rofecoxib
    Other Name: MK0966
  • Drug: Comparator: placebo (unspecified)
Not Provided
van Adelsberg J, Gann P, Ko AT, Damber JE, Logothetis C, Marberger M, Schmitz-Drager BJ, Tubaro A, Harms CJ, Roehrborn C. The VIOXX in Prostate Cancer Prevention study: cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups. Curr Med Res Opin. 2007 Sep;23(9):2063-70.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15000
December 2004
December 2004   (final data collection date for primary outcome measure)
Regular PSA testing and study biopsies required.
Male
50 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Puerto Rico,   United States
 
NCT00060476
0966-201, Formally-P30A03LD, MK0966-201, 2006_414
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP