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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01760460
First received: January 2, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Dyslipidemia
Drug: Anacetrapib
Drug: Placebo for anacetrapib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants who Experience at Least One Adverse Event (AE) [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Non-HDL-C [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01760460     History of Changes
Other Study ID Numbers: 0859-051, 132236
Study First Received: January 2, 2013
Last Updated: October 15, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anacetrapib
Oxazolidinones
Anti-Infective Agents
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014