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

NCT ID: NCT00653796

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-01
• Study Completion Date: 2004-08-01

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.

Conditions

Hypercholesterolemia; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ezetimibe + Atorvastatin

Group Type: EXPERIMENTAL

Ezetimibe + Atorvastatin

Intervention Type: DRUG

oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks

Atorvastatin

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks

Interventions

Ezetimibe + Atorvastatin

oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks

Intervention Type: DRUG

Atorvastatin

oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks

Intervention Type: DRUG

Other Intervention Names

SCH 58235; Zetia; Lipitor; Lipitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 17407633 (View on PubMed)

Other Identifiers

P03434

Identifier Type: -

Identifier Source: org_study_id