Endpoint Validation Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00533676
First received: September 19, 2007
Last updated: May 12, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Flushing
Drug: MK0524A, /Duration of Treatment : 8 Weeks
Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF). [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period. [ Time Frame: 8 weeks ]

Estimated Enrollment: 165
Study Start Date: August 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533676

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00533676     History of Changes
Other Study ID Numbers: 2007_612, MK0524A-015
Study First Received: September 19, 2007
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Flushing
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014