MK0524A Phase IIb Study (0524A-011)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00536237
First received: September 26, 2007
Last updated: August 24, 2015
Last verified: August 2015

September 26, 2007
August 24, 2015
August 2004
February 2005   (final data collection date for primary outcome measure)
To determine the effect of MK0524A on lipids and blood glucose [ Time Frame: 17 Weeks ]
Same as current
Complete list of historical versions of study NCT00536237 on ClinicalTrials.gov Archive Site
To establish the dose for limiting flushing symptoms induced by NIASPAN (R) [ Time Frame: 17 Weeks ]
Same as current
Not Provided
Not Provided
 
MK0524A Phase IIb Study (0524A-011)(COMPLETED)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Not Provided
Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. doi: 10.1016/j.amjcard.2007.10.023. Epub 2007 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
December 2006
February 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00536237
0524A-011, MK0524A-011, 2007_618
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP