Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)

Study Overview
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Brief Summary
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This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.

Official Title
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A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin

Conditions
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Hypercholesteremia, Hyperlipidemia

Intervention / Treatment
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* Drug: MK-0524A
* Drug: ER Niacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is appropriate candidate for niacin therapy Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1 Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1 Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1 Patient has TG <500 mg/dL (5.65 mmol/L) at V1 A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA Exclusion Criteria: Patients with unstable doses of medications Pregnant or lactating women, or women intending to become pregnant are excluded Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo → MK-0524A 2g<br>Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by MK-0524A 2 g for the remainder of the study (7 days). | Drug: MK-0524A<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Placebo → Extended Release (ER)-Niacin 2g<br>Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A Placebo for 5 days (drug holiday) followed by ER-Niacin 2g for the remainder of the study (7 days) | Drug: ER Niacin<br> <br> Drug: Placebo<br> <br> |
| Experimental: MK-0524A 2g<br>Following an 8-week active run-in (MK-0524A 1g (4 Weeks) then MK-0524A 2g (4 weeks) participants will be administered MK-0524A 2g for the remainder of the study (approximately 2 weeks). | Drug: MK-0524A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Flushing Severity Score (GFSS) during 7 days of treatment |  | during 7 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experience at Least 1 Adverse Event |  | up to 10 weeks | 
| Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event |  | up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed Hyperlipidemia, Primary Hypercholesteremia