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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00384293
Other study ID # 0524A-041
Secondary ID 2006_506
Status Terminated
Phase Phase 3
First received October 3, 2006
Last updated September 28, 2015
Start date September 2006
Est. completion date August 2008

Study information

Verified date September 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

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.


Recruitment information / eligibility

Status Terminated
Enrollment 937
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

Exclusion Criteria:

- A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study

- Patients with less than 80% drug study compliance

- Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window

- Patients with unstable dose of medications

- Pregnant or lactating women, or women intending to become pregnant are excluded

- Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

- Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)

Study Design

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


Intervention

Drug:
Comparator: niacin (+) laropiprant (MK0524A)
niacin (+) laropiprant (2 g) po qd.
Comparator: placebo
niacin (+) laropiprant (2 g) placebo po qd.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mean Carotid Intima Media Thickness change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery. after 96 weeks of postrandomization treatment No
Secondary Change in Lipid Profile after 96 weeks of postrandomization treatment No
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