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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Mixed Hyperlipidemia

Primary Hypercholesterolemia

Treatments

Drug: Comparator: niacin (+) laropiprant

Drug: niacin (+) laropiprant (+) simvastatin

Drug: Comparator: simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00269217

2005_098

0524B-022

MK0524B-022

Details and patient eligibility

About

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.

Enrollment

1,400 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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