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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: May 21, 2014
Last verified: May 2014

May 6, 2003
May 21, 2014
June 2003
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
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
February 2005
Not Provided

Regular PSA testing and study biopsies required.

Male
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00060476
0966-201, Formally-P30A03LD, MK0966-201, 2006_414
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

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