Clinical Trial: Lipid Efficacy Study (0524B-022)(COMPLETED)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholester
Brief Summary: This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
Original Primary Outcome: MK-0524B will be more efficacious in reducing LDL-C concentrations compared to MK-0524A.
Current Secondary Outcome:
- Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin.
- Coadministered MK0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK0524A.
Original Secondary Outcome: MK-0524B will have a greater effect on HDL-C, TG, LDL-C, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than simvastatin. MK-0524B will have a greater effect on HDL-C, TG, LDL-C:HDL-C, non-HDL-C, Apo B, and Apo A-I than MK-0524A.
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: December 21, 2005
Date Started: January 2006
Date Completion:
Last Updated: April 5, 2017
Last Verified: March 2017
