Study to Assess the Tolerability and Efficacy of Anacetrapib Co-administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020 AM1) (REALIZE)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01524289

First received: January 30, 2012

Last updated: March 27, 2013

Last verified: March 2013

History of Changes

Purpose

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	Intervention	Phase
Hyperlipoproteinemia Type II Heterozygous Familial Hypercholesterolemia	Drug: Anacetrapib Drug: Placebo for Anacetrapib	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	February 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01524289 History of Changes
Other Study ID Numbers:	0859-020, 2011-004525-27
Study First Received:	January 30, 2012
Last Updated:	March 27, 2013
Health Authority:	United States: Food and Drug Administration

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
Oxazolidinones
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013

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