Working… Menu
Trial record 5 of 16 for:    anacetrapib

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)

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: NCT01760460
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Anacetrapib Drug: Placebo for anacetrapib Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 14, 2013
Actual Primary Completion Date : March 4, 2015
Actual Study Completion Date : March 4, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Anacetrapib
Other Name: MK-0859

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.
Drug: Placebo for anacetrapib

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

Secondary Outcome Measures :
  1. Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [ Time Frame: Baseline and Week 24 ]
  2. Percent Change from Baseline in Non-HDL-C [ Time Frame: Baseline and Week 24 ]
  3. Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ]
  4. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ]
  5. Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications of Results:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01760460    
Other Study ID Numbers: 0859-051
132236 ( Registry Identifier: JAPIC-CTI )
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for 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