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

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

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Flushing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Comparator: niacin / Duration of Treatment: 17 Weeks

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No