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)

Phase 3

Completed

• Conditions: Heterozygous Familial Hypercholesterolemia (HeFH)
• Interventions: Drug: Placebo for anacetrapib; Drug: Anacetrapib

• Registration Number: NCT01824238
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo for anacetrapib	Participants will receive placebo tablet, orally, once daily for 12 weeks.
Anacetrapib	Anacetrapib	Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who Experience at Least One Adverse Event (AE)	12 weeks
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)	Baseline and Week 12
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)	Baseline and Week 12
Percent Change from Baseline in Lipoprotein(a) (Lp[a])	Baseline and Week 12
Percent Change from Baseline in Non-HDL-C	Baseline and Week 12
Percent Change from Baseline in Apolipoprotein B (Apo-B)	Baseline and Week 12