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

NCT01717300 | Completed Phase 3

• 2 other identifiers: 0859-0212012-003110-14
• Study Type: interventional
• Target: 459
• Locations: 0 countries
• Sites: N/A

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.

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 ≥3xULN (Upper Limit of Normal)

  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 <LLN (Lower Limit of Normal)

  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 (3)

Anacetrapib 100 mg

EXPERIMENTAL

Drug: Anacetrapib 100 mg; Drug: Placebo for anacetrapib 25 mg

Anacetrapib 25 mg

EXPERIMENTAL

Drug: Placebo for anacetrapib 100 mg; Drug: Anacetrapib 25 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo for anacetrapib 100 mg; Drug: Placebo for anacetrapib 25 mg

Interventions

Anacetrapib 100 mg DRUG

100 mg tablet, oral, once daily for 24 weeks

Also known as: MK-0859

Anacetrapib 100 mg

Placebo for anacetrapib 100 mg DRUG

Placebo tablet, orally, once daily for 24 weeks

Anacetrapib 25 mg; Placebo

Anacetrapib 25 mg DRUG

25 mg tablet, oral, once daily for 24 weeks

Also known as: MK-0859

Anacetrapib 25 mg

Placebo for anacetrapib 25 mg DRUG

Placebo tablet, orally, once daily for 24 weeks

Anacetrapib 100 mg; 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
• 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

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, 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.

  PMID: 27956003 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: October 26, 2012
• First Posted: October 30, 2012
• Study Start: November 6, 2012
• Primary Completion: October 29, 2014
• Study Completion: October 29, 2014
• Last Updated: April 17, 2017

Record last verified: 2017-04