A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
- Registration Number
- NCT00977288
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 anacetrapib MK0859 10 mg + placebo 8 anacetrapib MK0859 300 mg + atorvastatin 10mg 3 anacetrapib MK0859 100 mg + placebo 2 anacetrapib MK0859 40 mg + placebo 5 anacetrapib MK0859 10 mg + atorvastatin 10mg 4 anacetrapib MK0859 300 mg + placebo 7 anacetrapib MK0859 100 mg + atorvastatin 10mg 6 anacetrapib MK0859 40 mg + atorvastatin 10mg
- Primary Outcome Measures
Name Time Method The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8 8 weeks
- Secondary Outcome Measures
Name Time Method 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