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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00384293
Recruitment Status : Terminated
First Posted : October 6, 2006
Results First Posted : September 2, 2009
Last Update Posted : September 30, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Drug: Comparator: niacin (+) laropiprant (MK0524A) Drug: Comparator: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 937 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin

Arm Intervention/treatment
Experimental: 1
Drug: Comparator: niacin (+) laropiprant (MK0524A)
niacin (+) laropiprant (2 g) po qd.
Other Name: MK0524A

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

Primary Outcome Measures :
  1. Change in Mean Carotid Intima Media Thickness [ Time Frame: after 96 weeks of postrandomization treatment ]
    change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.

Secondary Outcome Measures :
  1. Change in Lipid Profile [ Time Frame: after 96 weeks of postrandomization treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00384293

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00384293     History of Changes
Other Study ID Numbers: 0524A-041
First Posted: October 6, 2006    Key Record Dates
Results First Posted: September 2, 2009
Last Update Posted: September 30, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs