Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435) (NCT00653835) | Clinical Trial Compass
CompletedPhase 4
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
153 participantsStarted 2003-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>=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 Criteria:
* 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 th…
What they're measuring
1
Percent change in LDL-C from baseline to endpoint.