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Completed

NCT Number: NCT01860729

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anacetrapib

Drug

Other names: MK-0859

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 23, 2013
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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