A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)

Merck Sharp & Dohme LLC0 sites165 target enrollmentAugust 2004

ConditionsFlushing

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Flushing
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 165
Primary Endpoint: To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
Status: Completed
Last Updated: 9 years ago

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

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

December 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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