Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Flushing

Treatments: Drug: Comparator : niacin /Duration of Treatment : 1 Weeks; Drug: MK0524A, /Duration of Treatment : 4 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533611

2007_604

0524A-056

MK0524A-056

Details and patient eligibility

About

The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is male or female between 18 and 70 years of age
• Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion criteria

• Patient has a history of hypersensitivity to niacin or niacin-containing products
• Patient is currently experiencing menopausal hot flashes
• Patient consumes more than 2 alcoholic beverages per day
• Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
• Patient engages in vigorous exercise or an aggressive diet regimen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind