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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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niacin (+) laropiprant

Duration of Treatment: 18 Weeks

Intervention Type DRUG

niacin

Duration of Treatment: 18 Weeks

Intervention Type DRUG

Other Intervention Names

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MK0524A

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No