Carotid IMT (Intima Media Thickening) Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00384293

Purpose

This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive 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.

Condition	Intervention	Phase
Hypercholesterolemia, Familial	Drug: Comparator: niacin (+) laropiprant (MK0524A) Drug: Comparator: placebo	Phase III

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Niacin Niacinamide Laropiprant Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Merck:

Primary Outcome Measures:

change in mean carotid intima media thickness [ Time Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in lipid profile [ Time Frame: after 96 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	900
Study Start Date:	September 2006
Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0524A	Drug: Comparator: niacin (+) laropiprant (MK0524A) niacin (+) laropiprant (2 g) po qd.
2: Placebo Comparator placebo	Drug: Comparator: placebo niacin (+) laropiprant (2 g) placebo po qd.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384293

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_506, MK0524A-041
Study First Received:	October 3, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00384293 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Niacinamide
Hyperlipidemias
Metabolic Diseases
Hyperlipoproteinemia Type II
Nicotinic Acids
Metabolism, Inborn Errors
Genetic Diseases, Inborn

Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Metabolic Disorder
Niacin
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Hyperlipidemias
Genetic Diseases, Inborn

Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009