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)

NCT ID: NCT01824238

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Heterozygous Familial Hypercholesterolemia (HeFH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anacetrapib

Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.

Group Type EXPERIMENTAL

Anacetrapib

Intervention Type DRUG

Placebo

Participants will receive placebo tablet, orally, once daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo for anacetrapib

Intervention Type DRUG

Interventions

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Anacetrapib

Intervention Type DRUG

Placebo for anacetrapib

Intervention Type DRUG

Other Intervention Names

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MK-0859

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Arai H, Teramoto T, Daida H, Ikewaki K, Maeda Y, Nakagomi M, Shirakawa M, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Vaidya S, Blaustein RO. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with heterozygous familial hypercholesterolemia. Atherosclerosis. 2016 Jun;249:215-23. doi: 10.1016/j.atherosclerosis.2016.03.017. Epub 2016 Mar 25.

Reference Type RESULT
PMID: 27131642 (View on PubMed)

Other Identifiers

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132234

Identifier Type: REGISTRY

Identifier Source: secondary_id

0859-050

Identifier Type: -

Identifier Source: org_study_id

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