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 is ongoing, but not recruiting participants.
Sponsor:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01524289
First Posted: February 1, 2012
Last Update Posted: July 28, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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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 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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Percent Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)(beta quantification method) [ Time Frame: Baseline and Week 52 ]
Secondary Outcome Measures:
- Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 52 ]
- Percent Change from Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 52 ]
- Percent Change from Baseline in Apolipoprotein B (Apo B) [ Time Frame: Baseline and Week 52 ]
- Percent Change from Baseline in Apolipoprotein A1 (Apo A1) [ Time Frame: Baseline and Week 52 ]
- Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 52 ]
| Enrollment: | 306 |
| Actual Study Start Date: | February 3, 2012 |
| Estimated Study Completion Date: | October 20, 2018 |
| Primary Completion Date: | February 12, 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
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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
No Contacts or Locations Provided
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 Submitted: | January 30, 2012 |
| First Posted: | February 1, 2012 |
| Last Update Posted: | July 28, 2017 |
| Last Verified: | July 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 |