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

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: NCT01524289
Recruitment Status : Active, not recruiting
First Posted : February 1, 2012
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperlipoproteinemia Type II Heterozygous Familial Hypercholesterolemia Drug: Anacetrapib Drug: Placebo for Anacetrapib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 3, 2012
Actual Primary Completion Date : February 12, 2014
Estimated Study Completion Date : October 20, 2018

Arm Intervention/treatment
Experimental: Anacetrapib Drug: Anacetrapib
one 100 mg tablet, orally once daily for 52 weeks
Other Name: MK-0859

Placebo Comparator: Placebo Drug: Placebo for Anacetrapib
one tablet, orally, once daily for 52 weeks

Primary Outcome Measures :
  1. Percent Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)(beta quantification method) [ Time Frame: Baseline and Week 52 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 52 ]
  2. Percent Change from Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 52 ]
  3. Percent Change from Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 52 ]
  4. Percent Change from Baseline in Apolipoprotein A1 (Apo A1) [ Time Frame: Baseline and Week 52 ]
  5. Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 52 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01524289     History of Changes
Other Study ID Numbers: 0859-020
2011-004525-27 ( EudraCT Number )
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors