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

NCT01860729 | Completed Phase 3

• 1 other identifier: 0859-022
• Study Type: interventional
• Target: 589
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (7)

• Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)

  Baseline and Week 24

• Percent Change from Baseline in HDL-C

  Baseline and Week 24

• Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN)

  24 weeks

• Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms

  24 weeks

• Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN)

  24 weeks

• Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause

  24 weeks

• Number of Participants with Significant Increase in Blood Pressure

  24 weeks

Secondary Outcomes (5)

• Percent Change from Baseline in non-HDL-C

  Baseline and Week 24

• Percent Change from Baseline in Apolipoprotein B (Apo-B)

  Baseline and Week 24

• Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)

  Baseline and Week 24

• Percent Change from Baseline in Lipoprotein(a) (lp[a])

  Baseline and Week 24

• Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal

  Baseline and Week 24

Study Arms (2)

Anacetrapib

EXPERIMENTAL

100 mg tablet, oral, once daily for 24 weeks

Drug: Anacetrapib

Placebo

PLACEBO COMPARATOR

Matching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks

Drug: Placebo

Interventions

Anacetrapib DRUG

Also known as: MK-0859

Anacetrapib

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ballantyne CM, Shah S, Sapre A, Ashraf TB, Tobias SC, Sahin T, Ye P, Dong Y, Sheu WH, Kang DH, Ferreira Rossi PR, Moiseeva Y, Briones IR, Johnson-Levonas AO, Mitchel YB. A Multiregional, Randomized Evaluation of the 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 Aug 15;120(4):569-576. doi: 10.1016/j.amjcard.2017.03.255. Epub 2017 Apr 12.

  PMID: 28624096 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: May 13, 2013
• Primary Completion: May 29, 2015
• Study Completion: August 20, 2015
• Last Updated: May 29, 2020

Record last verified: 2020-05