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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Anacetrapib
* Drug: Placebo for anacetrapib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anacetrapib<br>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<br> <br> * Other names: MK-0859;|
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |