Status:
COMPLETED
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolaemia
Atherosclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 admi...
Eligibility Criteria
Inclusion
- \>=18 years and \<= 75 years of age
- LDL-C concentration \>= 3.3 mmol/L (130 mg/dL) to \<= 4.9 mmol/L (190 mg/dL) at baseline.
- Triglyceride concentration \<3.99 mmol/L (350 mg/dL) at baseline.
- 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.
- Stable weight history for at least 4 weeks prior to entry into study at baseline.
- Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
Exclusion
- Body mass index (BMI) \>=35 kg/m\^2 at baseline.
- Subjects whose liver transaminases (ALT, AST) are \>1.5 times the upper limit of normal and with active liver diseases at baseline.
- Subjects with evidence of current myopathy (including subjects with CK\>1.5 times above the upper limit of normal) at baseline.
- Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline.
- 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.
- 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.
- Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
- Female subjects who consume \>14 units and male subjects who consume \>21 units of alcohol per week.
- Female subjects who are pregnant or breast feeding.
- Subjects who have not observed the designated washout periods for any of the prohibited medications.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00653835
Start Date
September 1 2003
End Date
August 1 2004
Last Update
August 15 2024
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