Overview

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)

Status:
Completed
Trial end date:
2015-03-04
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Anacetrapib
Oxazolidinones
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