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)

NCT01824238 | Completed Phase 3

• 2 other identifiers: 0859-050132234
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Outcome Measures

Primary Outcomes (2)

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

  Baseline and Week 12

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

  12 weeks

Secondary Outcomes (5)

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

  Baseline and Week 12

• Percent Change from Baseline in Non-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 Apolipoprotein B (Apo-B)

  Baseline and Week 12

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

  Baseline and Week 12

Study Arms (2)

Anacetrapib

EXPERIMENTAL

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

Drug: Anacetrapib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for anacetrapib

Interventions

Anacetrapib DRUG

Also known as: MK-0859

Anacetrapib

Placebo for anacetrapib DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 27131642 RESULT

MeSH Terms

Interventions

anacetrapib

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 25, 2016

Record last verified: 2016-04