A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Treatments

Drug: Anacetrapib

Drug: Placebo for anacetrapib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01824238

132234 (Registry Identifier)

0859-050

Details and patient eligibility

About

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 heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.

Enrollment

68 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

If female, cannot be of reproductive potential
Diagnosed with heterozygous familial hypercholesterolemia
Have been treated with an appropriate and

stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks

Exclusion criteria

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