Lipid Efficacy/Tolerability Study (0524A-020)

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

1620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Hypercholesterolaemia Mixed Hyperlipidaemia

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 - 24 weeks

Intervention Type DRUG

ER-niacin

Duration of Treatment - 24 weeks

Intervention Type DRUG

Other Intervention Names

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MK0524A

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No