MK0524A Phase IIb Study (0524A-011)(COMPLETED)
Primary Purpose
Flushing
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: niacin / Duration of Treatment: 17 Weeks
MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Flushing
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
To determine the effect of MK0524A on lipids and blood glucose
Secondary Outcome Measures
To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
Full Information
NCT ID
NCT00536237
First Posted
September 26, 2007
Last Updated
August 24, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00536237
Brief Title
MK0524A Phase IIb Study (0524A-011)(COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flushing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Comparator: niacin / Duration of Treatment: 17 Weeks
Intervention Type
Drug
Intervention Name(s)
MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
Primary Outcome Measure Information:
Title
To determine the effect of MK0524A on lipids and blood glucose
Time Frame
17 Weeks
Secondary Outcome Measure Information:
Title
To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
Time Frame
17 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18308010
Citation
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.
Results Reference
background
Learn more about this trial
MK0524A Phase IIb Study (0524A-011)(COMPLETED)
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