Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: atorvastatin; Drug: ezetimibe and atorvastatin; Drug: Placebo (unspecified)

• Registration Number: NCT00418834
• Lead Sponsor: Organon and Co

Brief Summary

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-08-25
• Results First Submitted QC: 2009-08-31
• Results First Posted: 2009-10-06
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1053

Inclusion Criteria

• Patient is age 65 or older
• Patient is willing to maintain cholesterol lowering diet
• Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category

Exclusion Criteria

• A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study
• Patient is unlikely to be compliant in taking study medication
• Patient with chronic or unstable medical condition
• Patient is taking unstable doses of medication
• Patient drinks more than 2 alcoholic drinks per day
• Patient has elevations in certain laboratory values (CK, AST, ALT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	atorvastatin	-
2	Placebo (unspecified)	-
1	ezetimibe and atorvastatin	-
1	Placebo (unspecified)	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C at Week 6	Baseline and Week 6

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6	Week 6
Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12	Week 12
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6	Week 6
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12	Week 12