Lipid Efficacy Study (0524B-022)(COMPLETED)

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia; Mixed Hyperlipidemia

• Registration Number: NCT00269217
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Description

Not available

Study Timeline

• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-23
• Study Start: 2006-01
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
• LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides </= 350 mg/dL.

Exclusion Criteria

• A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
• Patients with <80% compliance
• Patients with certain medical conditions
• Patients taking certain concomitant medications and/or with unstable doses of medications
• Or those with a history of CHD/CHD equivalent or diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.

Secondary Outcome Measures

Name	Time	Method
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.