Lipid Efficacy/Tolerability Study (0524A-020)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Mixed Hyperlipidaemia

Primary Hypercholesterolaemia

Treatments

Drug: ER-niacin

Drug: niacin (+) laropiprant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00269204

0524A-020

MK0524A-020

2005_095

Details and patient eligibility

About

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.

Enrollment

1,620 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 with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
Have medical conditions considered to be CHD equivalent).
LDL-C below 130 mg/dL for patients with multiple risk factors.
LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides </= to 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 < 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications.
Pregnant or lactating women, or women intending to become pregnant are excluded.
Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).