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

Merck Sharp & Dohme LLC1,400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,400

Conditions

Primary Hypercholesterolemia Mixed Hyperlipidemia

Interventions

niacin (+) laropiprant (+) simvastatinDRUG

Duration of Treatment 12 Weeks

Comparator: niacin (+) laropiprantDRUG

Duration of Treatment 12 Weeks

Comparator: simvastatinDRUG

Duration of Treatment 12 Weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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