Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Hyperlipidemia

Hypercholesterolemia

Treatments

Drug: niacin (+) laropiprant

Drug: niacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00378833

0524A-054

2006_529

Details and patient eligibility

About

This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

Enrollment

1,300 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

Exclusion criteria

Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin
Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.
Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.