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Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)

Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia; Atherosclerosis

Intervention: Ezetimibe + Atorvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Schering-Plough

Summary

This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment na´ve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.

Clinical Details

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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent change in LDL-C from baseline to endpoint.

Secondary outcome:

Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.

Safety: adverse events, laboratory test results, vital signs.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 2003
Ending date: August 2004
Last updated: April 4, 2008

Page last updated: June 20, 2008

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