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)

NCT01760460 | Completed Phase 3

• 2 other identifiers: 0859-051132236
• Study Type: interventional
• Target: 307
• 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 dyslipidemia when added to an existing statin-modifying therapy.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

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

  Baseline and Week 24

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

  64 weeks

Secondary Outcomes (5)

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

  Baseline and Week 24

• Percent Change from Baseline in Non-HDL-C

  Baseline and Week 24

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

  Baseline and Week 24

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

  Baseline and Week 24

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

  Baseline and Week 24

Study Arms (2)

Anacetrapib

EXPERIMENTAL

Participants will receive 100-mg anacetrapib, orally, once-daily for 24 weeks. Participants will continue on once-daily 100-mg anacetrapib during 28 week open-label extension.

Drug: Anacetrapib

Placebo

PLACEBO COMPARATOR

Participants will receive placebo tablet, orally, once daily for 24 weeks. Participants will be switched to once-daily 100-mg anacetrapib during 28 week open-label extension.

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Teramoto T, Daida H, Ikewaki K, Arai H, Maeda Y, Nakagomi M, Shirakawa M, Watanabe Y, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Blaustein RO. Lipid-modifying efficacy and tolerability of anacetrapib added to ongoing statin therapy in Japanese patients with dyslipidemia. Atherosclerosis. 2017 Jun;261:69-77. doi: 10.1016/j.atherosclerosis.2017.03.009. Epub 2017 Mar 10.

  PMID: 28478132 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: January 2, 2013
• First Posted: January 4, 2013
• Study Start: March 14, 2013
• Primary Completion: March 4, 2015
• Study Completion: March 4, 2015
• Last Updated: June 1, 2017

Record last verified: 2017-05