Endpoint Validation Study (0524A-015)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Flushing

Treatments: Drug: MK0524A, /Duration of Treatment : 8 Weeks; Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533676

MK0524A-015

2007_612

0524A-015

Details and patient eligibility

About

To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be male or female between 18 to 70 years
• Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control

Exclusion criteria

• You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
• You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
• You are sensitive to niacin
• You have a history gout
• You drink more than 2 glasses of alcohol per day and you are not willing to stop
• You don't have access to a telephone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind