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

Flushing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536237
• Other study ID #: 0524A-011
• Secondary ID: MK0524A-0112007_
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2007
• Last updated: August 24, 2015
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2006
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flushing

Intervention

Drug:
• Comparator: niacin / Duration of Treatment: 17 Weeks

• MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks

• Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of MK0524A on lipids and blood glucose		17 Weeks
Secondary	To establish the dose for limiting flushing symptoms induced by NIASPAN (R)		17 Weeks