Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
Study Details
Study Description
Brief Summary
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ezetimibe + Simvastatin
|
Drug: Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
Other Names:
|
| Active Comparator: Simvastatin
|
Drug: Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent change in LDL-C from baseline to endpoint. [6 weeks]
Secondary Outcome Measures
- Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. [6 weeks]
- Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. [6 weeks]
- Safety: adverse events, laboratory test results, vital signs. [Throughout study]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
=18 years and <= 75 years of age
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LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) at baseline.
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Triglyceride concentration <3.99 mmol/L (350 mg/dL) at baseline.
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Documented coronary heart disease (CHD), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of MI; history of PCI (primarily PTCA with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-Q wave MI.
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Stable weight history for at least 4 weeks prior to entry into study at baseline.
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Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
Exclusion Criteria:
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Body mass index (BMI) >=35 kg/m^2 at baseline.
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Subjects whose liver transaminases (ALT, AST) are >1.5 times the upper limit of normal and with active liver diseases at baseline.
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Subjects with evidence of current myopathy (including subjects with CK>1.5 times above the upper limit of normal) at baseline.
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Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline.
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Subjects with Type II diabetes mellitus who are poorly controlled (HbA1c>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline.
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Subjects with Type I diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control.
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Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
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Female subjects who consume >14 units and male subjects who consume >21 units of alcohol per week.
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Female subjects who are pregnant or breast feeding.
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Subjects who have not observed the designated washout periods for any of the prohibited medications.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P03435