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OpenTrials
Completed

NCT Number: NCT01760460

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

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 dyslipidemia when added to an existing statin-modifying therapy.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

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
  • Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines

Exclusion criteria

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous and heterozygous 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 24

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

    Time frame: 64 weeks

Secondary outcomes

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

    Time frame: Baseline and Week 24

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

    Time frame: Baseline and Week 24

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

    Time frame: Baseline and Week 24

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

    Time frame: Baseline and Week 24

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

    Time frame: Baseline and Week 24

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, 24-Week, Double-Blind, Randomized, Placebo-Controlled, Phase III Study With 28-Week Open Labeled Extension Period to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Japanese Patients With Dyslipidemia

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2013
Registry last updated
Jun 1, 2017

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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