Endpoint Validation Study (0524A-015)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00533676
First received: September 19, 2007
Last updated: August 1, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00533676     History of Changes
Other Study ID Numbers: 0524A-015, MK0524A-015, 2007_612
Study First Received: September 19, 2007
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Flushing
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014