A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)

Study Overview
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Brief Summary
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This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.

Detailed Description
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This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients. Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period. As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.

Official Title
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A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: anacetrapib
* Drug: Comparator: atorvastatin
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia Exclusion Criteria: Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes) Patients has uncontrolled diabetes Patient is currently participating or has participated in a study with an investigational compound within the last 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: 1<br>MK0859 10 mg + placebo | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: Placebo<br>* Placebo tablet, once daily for 8 weeks<br>|
| Experimental: 2<br>MK0859 40 mg + placebo | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: Placebo<br>* Placebo tablet, once daily for 8 weeks<br>|
| Experimental: 3<br>MK0859 100 mg + placebo | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: Placebo<br>* Placebo tablet, once daily for 8 weeks<br>|
| Experimental: 4<br>MK0859 300 mg + placebo | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: Placebo<br>* Placebo tablet, once daily for 8 weeks<br>|
| Experimental: 5<br>MK0859 10 mg + atorvastatin 10mg | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: atorvastatin<br>* atorvastatin tablet, 10mg, once daily for 8 weeks<br>|
| Experimental: 6<br>MK0859 40 mg + atorvastatin 10mg | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: atorvastatin<br>* atorvastatin tablet, 10mg, once daily for 8 weeks<br>|
| Experimental: 7<br>MK0859 100 mg + atorvastatin 10mg | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: atorvastatin<br>* atorvastatin tablet, 10mg, once daily for 8 weeks<br>|
| Experimental: 8<br>MK0859 300 mg + atorvastatin 10mg | Drug: anacetrapib<br>* 10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks<br>* Other names: MK0859;Drug: Comparator: atorvastatin<br>* atorvastatin tablet, 10mg, once daily for 8 weeks<br>|
| Placebo Comparator: 9<br>Placebo + atorvastatin 10mg | Drug: Comparator: atorvastatin<br>* atorvastatin tablet, 10mg, once daily for 8 weeks<br>Drug: Comparator: Placebo<br>* Placebo tablet, once daily for 8 weeks<br>|
| Placebo Comparator: 10<br>Placebo | Drug: Comparator: Placebo<br>* Placebo tablet, once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8 |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8 |  | 8 weeks |