NCT00384293

Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)

A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 937 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.

Conditions

• Hypercholesterolemia, Familial

Interventions

Type	Name	Description
DRUG	Comparator: niacin (+) laropiprant (MK0524A)	niacin (+) laropiprant (2 g) po qd.
DRUG	Comparator: placebo	niacin (+) laropiprant (2 g) placebo po qd.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-10-06
• Last updated: 2015-09-30
• Results posted: 2009-09-02