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Study to Assess the Tolerability and Efficacy of Anacetrapib Co-administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020) (REALIZE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01524289
First received: January 30, 2012
Last updated: May 29, 2014
Last verified: May 2014

January 30, 2012
May 29, 2014
February 2012
February 2014   (final data collection date for primary outcome measure)
Percent Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)(beta quantification method) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Percent Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01524289 on ClinicalTrials.gov Archive Site
  • Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein A1 (Apo A1) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Tolerability and Efficacy of Anacetrapib Co-administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
A 1-Year, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo- Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Heterozygous Familial Hypercholesterolemia

The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hyperlipoproteinemia Type II
  • Heterozygous Familial Hypercholesterolemia
  • Drug: Anacetrapib
    one 100 mg tablet, orally once daily for 52 weeks
    Other Name: MK-0859
  • Drug: Placebo for Anacetrapib
    one tablet, orally, once daily for 52 weeks
  • Experimental: Anacetrapib
    Intervention: Drug: Anacetrapib
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo for Anacetrapib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • If of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study
  • Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH)
  • Have been treated with an optimal dose of statin for at least 6 weeks

Exclusion Criteria:

  • Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of screening or expect to undergo treatment with LDL apheresis during the course of the study
  • Homozygous familial hypercholesterolemia
  • Severe chronic heart failure
  • Uncontrolled hypertension
  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), unstable angina, or stroke within 3 months
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Active or chronic hepatobiliary, hepatic, or gall bladder disease
  • Pregnant or breast-feeding, or plans to become pregnant during the

study or within 2 years after stopping study mediation

  • History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
  • Human immunodeficiency virus (HIV) positive
  • History of malignancy ≤5 years
  • Donated blood products or has had phlebotomy of >300 mL within 8

weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study

  • Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior
  • Consumes more than 2 alcoholic drinks per day
  • Currently participating or has participated in a study with an investigational compound or device within 3 months
  • Receiving treatment with systemic corticosteroids or taking systemic anabolic agents
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01524289
0859-020, 2011-004525-27
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

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