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OpenTrials
Completed

NCT Number: NCT01824238

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)

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.

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Key information

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anacetrapib

Drug

Other names: MK-0859

Placebo for anacetrapib

Drug

Primary outcomes

  1. Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)

    Time frame: Baseline and Week 12

  2. Percentage of Participants who Experience at Least One Adverse Event (AE)

    Time frame: 12 weeks

Secondary outcomes

  1. Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)

    Time frame: Baseline and Week 12

  2. Percent Change from Baseline in Non-HDL-C

    Time frame: Baseline and Week 12

  3. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)

    Time frame: Baseline and Week 12

  4. Percent Change from Baseline in Apolipoprotein B (Apo-B)

    Time frame: Baseline and Week 12

  5. Percent Change from Baseline in Lipoprotein(a) (Lp[a])

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2013
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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