Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434) (NCT00653796) | Clinical Trial Compass
CompletedPhase 4
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
148 participantsStarted 2003-09-01
Plain-language summary
This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male and non-pregnant female subjects, who demonstrated willingness to participate and comply with procedures by signing informed consent, and who were \>=18 years and \<=75 years of age, were eligible to participate if they had: a baseline LDL-C concentration \>=3.3 mmol/L (130 mg/dL) to \<=4.9 mmol/L (190 mg/dL); a baseline triglyceride concentration of \<3.99 mmol/L (350 mg/dL); a documented history of coronary heart disease (CHD); a stable weight history for 4 weeks prior to baseline; completion of the designated washout periods for all prohibited medications; and did not fulfill any of the exclusion criteria for the study.
Exclusion Criteria:
* Body Mass Index of \>=30 kg/m\^2 at baseline (increased to 35 kg/m\^2 in protocol amendment 1
* Liver transaminase (ALT, AST) \>1.5 times the upper limit of normal and with no active liver disease at baseline
* Evidence of current myopathy (excluding subjects with CK \>1.5 times above the upper limit of normal at baseline
* Clinical lab tests (CBC, blood chemistries, urinalysis) results outside the normal range or unacceptable to the investigator at baseline
* Type II diabetes mellitus that was poorly controlled (HbA1c\>9%), newly diagnosed, or changed their anti-diabetic therapy within 3 months of baseline
* Type I diabetes mellitus and not on a stable insulin regimen for 3 months prior to baseline or who had a recent history of repeated hypoglycaemia or unstable glycaemic control
* Known hypersensitivity…
What they're measuring
1
Percent change in LDL-C from baseline to endpoint.