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)
- Registration Number
- NCT01760460
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 307
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo for anacetrapib 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. Anacetrapib Anacetrapib 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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