A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy (MK-0859-022)

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: NCT01860729
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : August 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the effects 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 therapy.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Anacetrapib Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 589 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
Study Start Date : May 2013
Primary Completion Date : May 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 ≥3x Upper Limit of Normal (ULN) [ 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 <Lower Limit of Normal (LLN) [ 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 ]

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

Inclusion Criteria:

  • If female, cannot be of reproductive potential
  • Has been treated with an appropriate 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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01860729     History of Changes
Other Study ID Numbers: 0859-022
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors