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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Flushing

Treatments

Drug: Comparator: niacin / Duration of Treatment: 17 Weeks

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

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

Study type

Interventional

Funder types

Industry

Identifiers

MK0524A-011

2007_618

0524A-011

Details and patient eligibility

About

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.

Enrollment

154 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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