Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

• Status: Completed
• Trial end date: 2010-08-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL

Exclusion Criteria:

• Pregnant or lactating women, or women intending to become pregnant

• Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)

• Human immunodeficiency virus (HIV) positive

• Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty

• Active or chronic liver disease