A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

Overview

This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with dyslipidemia when added to an existing statin-modifying therapy.

Full Title of Study: “A Multicenter, 24-Week, Double-Blind, Randomized, Placebo-Controlled, Phase III Study With 28-Week Open Labeled Extension Period to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Japanese Patients With Dyslipidemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 4, 2015

Interventions

  • Drug: Anacetrapib
  • Drug: Placebo for anacetrapib

Arms, Groups and Cohorts

  • Experimental: Anacetrapib
    • Participants will receive 100-mg anacetrapib, orally, once-daily for 24 weeks. Participants will continue on once-daily 100-mg anacetrapib during 28 week open-label extension.
  • Placebo Comparator: Placebo
    • Participants will receive placebo tablet, orally, once daily for 24 weeks. Participants will be switched to once-daily 100-mg anacetrapib during 28 week open-label extension.

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
    • Time Frame: Baseline and Week 24
  • Percentage of Participants who Experience at Least One Adverse Event (AE)
    • Time Frame: 64 weeks

Secondary Measures

  • Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)
    • Time Frame: Baseline and Week 24
  • Percent Change from Baseline in Non-HDL-C
    • Time Frame: Baseline and Week 24
  • Percent Change from Baseline in Apolipoprotein B (Apo-B)
    • Time Frame: Baseline and Week 24
  • Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
    • Time Frame: Baseline and Week 24
  • Percent Change from Baseline in Lipoprotein(a) (Lp[a])
    • Time Frame: Baseline and Week 24

Participating in This Clinical Trial

Inclusion Criteria

  • If female, cannot be of reproductive potential
  • Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines

Exclusion Criteria

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous and heterozygous 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Teramoto T, Daida H, Ikewaki K, Arai H, Maeda Y, Nakagomi M, Shirakawa M, Watanabe Y, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Blaustein RO. Lipid-modifying efficacy and tolerability of anacetrapib added to ongoing statin therapy in Japanese patients with dyslipidemia. Atherosclerosis. 2017 Jun;261:69-77. doi: 10.1016/j.atherosclerosis.2017.03.009. Epub 2017 Mar 10.

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