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

NCT00384293 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 937

Last updated 2015-09-30

Study results available
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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

DRUG

Comparator: niacin (+) laropiprant (MK0524A)

niacin (+) laropiprant (2 g) po qd.

DRUG

Comparator: placebo

niacin (+) laropiprant (2 g) placebo po qd.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00384293 on ClinicalTrials.gov