Status:
COMPLETED
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia
Atherosclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 to HMG-CoA reductase inhibitors
- Alcohol consumption \>14 units (women)/21 units (men) (unit = 0.5 pint of beer or wine, or single measure of spirits)
- Pregnancy, lactation, or any condition or situation which, in the opinion of the investigator, posed a risk to the subject or interfered with participation in this study.
- Any of the following medical conditions: HIV positive; congestive heart failure defined by NYHA as Class III or IV; uncontrolled cardiac arrhythmia; MI, acute coronary insufficiency, CABG, or angioplasty within 3 months of baseline; unstable or severe peripheral artery disease within 3 months of baseline; newly diagnosed or unstable angina pectoris at baseline; uncontrolled hypertension with systolic blood pressure \>100 mm Hg at baseline; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins; impaired renal function or nephritic syndrome at baseline; disorders of the hematological, gastrointestinal, or central nervous systems; diseases other than hyperlipidaemia or coronary heart disease that would have interfered with study evaluations; and cancer.
- Drug abuse or emotional or intellectual problems;
- Use of certain drugs, food, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or atorvastatin
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00653796
Start Date
September 1 2003
End Date
August 1 2004
Last Update
August 15 2024
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