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
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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COMPLETED
PHASE3
68 participants
INTERVENTIONAL
2013-05-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anacetrapib
Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.
Anacetrapib
Placebo
Participants will receive placebo tablet, orally, once daily for 12 weeks.
Placebo for anacetrapib
Interventions
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Anacetrapib
Placebo for anacetrapib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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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.
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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