Endpoint Validation Study (0524A-015)

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Oxymetazoline

Criteria

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