MK0524A Phase IIb Study (0524A-011)(COMPLETED)

Merck Sharp & Dohme LLC154 enrolled

Overview

Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone. Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Flushing

Interventions

Comparator: niacin / Duration of Treatment: 17 WeeksDRUG

MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 WeeksDRUG

Comparator: placebo (unspecified) / Duration of Treatment: 17 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking \> 50mg at screening * Must be willing to complete electronic diary Exclusion Criteria: * Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT) * You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive * You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

Outcomes

Primary Outcomes

To determine the effect of MK0524A on lipids and blood glucose

Time frame: 17 Weeks

Secondary Outcomes

To establish the dose for limiting flushing symptoms induced by NIASPAN (R)

Time frame: 17 Weeks

Data from ClinicalTrials.gov

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