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

Merck Sharp & Dohme LLC1,300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,300

Conditions

Hypercholesterolemia Hyperlipidemia

Interventions

niacin (+) laropiprantDRUG

Duration of Treatment: 18 Weeks

niacinDRUG

Duration of Treatment: 18 Weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Global Flushing Severity Score (GFSS) over 16 weeks

Secondary Outcomes

Safety/tolerability

Data from ClinicalTrials.gov

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