Clinical trial NCT00653796: Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
Official title: SCH 58235: A Multicentre, Randomised, Parallel Group, Placebo-Controlled Study Comparing the Efficacy, Safety, And Tolerability of the Daily Co-Administration of Ezetimibe 10 mg With Atorvastatin 10 mg vs. Ezetimibe Placebo With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolaemia and Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Atherosclerosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-04-07
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for reducing LDL-concentrations.


Eligibility criteria: 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 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

Primary outcomes:
measure: Percent change in LDL-C from baseline to endpoint.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.
timeFrame: 6 weeks
measure: Safety: adverse events, laboratory test results, vital signs.
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
References:
citation: Blagden MD, Chipperfield R. Efficacy and safety of ezetimibe co-administered with atorvastatin in untreated patients with primary hypercholesterolaemia and coronary heart disease. Curr Med Res Opin. 2007 Apr;23(4):767-75. doi: 10.1185/030079907x182059.