Endpoint Validation Study (0524A-015)

Phase 2

Completed

• Conditions: Flushing

• Registration Number: NCT00533676
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).	8 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.	8 weeks