MK0524A Phase IIb Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00536237
First received: September 26, 2007
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.

Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.


Condition Intervention Phase
Flushing
Drug: Comparator: niacin / Duration of Treatment: 17 Weeks
Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the effect of MK0524A on lipids and blood glucose [ Time Frame: 17 Weeks ]

Secondary Outcome Measures:
  • To establish the dose for limiting flushing symptoms induced by NIASPAN (R) [ Time Frame: 17 Weeks ]

Estimated Enrollment: 450
Study Start Date: June 2004
Study Completion Date: June 2004
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
  • Must be willing to complete electronic diary

Exclusion Criteria:

  • Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
  • You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
  • You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
  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: NCT00536237

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: NCT00536237     History of Changes
Other Study ID Numbers: 2007_618, MK0524A-011
Study First Received: September 26, 2007
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Flushing
Signs and Symptoms
Niacin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014