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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia

Treatments: Drug: Anacetrapib; Drug: Placebo for anacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01760460

132236 (Registry Identifier)

0859-051

Details and patient eligibility

About

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.

Enrollment: 307 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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307 participants in 2 patient groups, including a placebo group

Anacetrapib

Experimental group

Description:

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.

Treatment:

Drug: Anacetrapib

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo for anacetrapib