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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00384293
First received: October 3, 2006
Last updated: October 6, 2014
Last verified: October 2014

October 3, 2006
October 6, 2014
September 2006
August 2008   (final data collection date for primary outcome measure)
Change in Mean Carotid Intima Media Thickness [ Time Frame: after 96 weeks of postrandomization treatment ] [ Designated as safety issue: No ]
change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.
Change in mean carotid intima media thickness after 96 weeks of treatment
Complete list of historical versions of study NCT00384293 on ClinicalTrials.gov Archive Site
Change in Lipid Profile [ Time Frame: after 96 weeks of postrandomization treatment ] [ Designated as safety issue: No ]
Change in lipid profile after 96 weeks of treatment
Not Provided
Not Provided
 
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia, Familial
  • Drug: Comparator: niacin (+) laropiprant (MK0524A)
    niacin (+) laropiprant (2 g) po qd.
    Other Name: MK0524A
  • Drug: Comparator: placebo
    niacin (+) laropiprant (2 g) placebo po qd.
  • Experimental: 1
    MK0524A
    Intervention: Drug: Comparator: niacin (+) laropiprant (MK0524A)
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Comparator: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
937
August 2008
August 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00384293
0524A-041, 2006_506
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP