A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)

Study Description

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

Brief Summary:

This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin-modifying therapy.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Anacetrapib 100 mg; Drug: Placebo for anacetrapib 100 mg; Drug: Anacetrapib 25 mg; Drug: Placebo for anacetrapib 25 mg	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	459 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A 24-Week, 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 Hypercholesterolemia or Low HDL-C
Actual Study Start Date :	November 6, 2012
Actual Primary Completion Date :	October 29, 2014
Actual Study Completion Date :	October 29, 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Anacetrapib 100 mg	Drug: Anacetrapib 100 mg; 100 mg tablet, oral, once daily for 24 weeks; Other Name: MK-0859 Drug: Placebo for anacetrapib 25 mg; Placebo tablet, orally, once daily for 24 weeks
Experimental: Anacetrapib 25 mg	Drug: Placebo for anacetrapib 100 mg; Placebo tablet, orally, once daily for 24 weeks Drug: Anacetrapib 25 mg; 25 mg tablet, oral, once daily for 24 weeks; Other Name: MK-0859
Placebo Comparator: Placebo	Drug: Placebo for anacetrapib 100 mg; Placebo tablet, orally, once daily for 24 weeks Drug: Placebo for anacetrapib 25 mg; Placebo tablet, orally, once daily for 24 weeks

Outcome Measures

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Primary Outcome Measures :

1. Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ]
2. Percent Change from Baseline in HDL-C [ Time Frame: Baseline and Week 24 ]
3. Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal) [ Time Frame: 24 Weeks ]
4. Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 24 weeks ]
5. Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal) [ Time Frame: 24 weeks ]
6. Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause [ Time Frame: 24 weeks ]
7. Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. Percent change from Baseline in non-HDL-C [ Time Frame: Baseline and Week 24 ]
2. Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ]
3. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ]
4. Percent Change from Baseline in Lipoprotein(a) (lp[a]) [ Time Frame: Baseline and Week 24 ]
5. Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal [ Time Frame: Baseline and Week 24 ]

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 female, cannot be of reproductive potential
• Have been treated with an optimal dose of statin for at least 6 weeks
• Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal

Exclusion Criteria:

• Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
• Homozygous familial hypercholesterolemia
• Severe chronic heart failure
• Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
• Uncontrolled hypertension
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
• Active or chronic hepatobiliary, hepatic, or gall bladder disease
• History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable
• 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 of Results:

Ballantyne CM, Shah S, Kher U, Hunter JA, Gill GG, Cressman MD, Ashraf TB, Johnson-Levonas AO, Mitchel YB. Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients with Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Feb 1;119(3):388-396. doi: 10.1016/j.amjcard.2016.10.032. Epub 2016 Nov 1.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01717300 History of Changes
Other Study ID Numbers:	0859-021; 2012-003110-14 ( EudraCT Number )
First Posted:	October 30, 2012
Last Update Posted:	April 17, 2017
Last Verified:	April 2017

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Anacetrapib; Oxazolidinones; Anticholesteremic Agents	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors