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

Hypercholesterolemia, Familial Clinical Trial

— ACHIEVE  

Official title:

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)

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipoproteinemia Type II

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