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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)

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

Study Description
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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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov 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:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
 Anacetrapib
Oxazolidinones
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors