EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-02-28

Brief Summary

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In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (\> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.

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Detailed Description

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Patients with simvastatin 20 mg or atorvastatin 10 mg were randomized to (1) double statin dose (to 40 mg simvastatin or 20 mg atorvastatin) or (2) switch to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Arm 1: Active comparator

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets

atorvastatin

Intervention Type DRUG

20 mg atorvastatin once daily for 12 weeks. Tablets

2

Arm 2: Drug

Group Type EXPERIMENTAL

ezetimibe (+) simvastatin

Intervention Type DRUG

Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets

Interventions

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ezetimibe (+) simvastatin

Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets

Intervention Type DRUG

simvastatin

Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets

Intervention Type DRUG

atorvastatin

20 mg atorvastatin once daily for 12 weeks. Tablets

Intervention Type DRUG

Other Intervention Names

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MK0653A Vytorin® INEGY™ MK0733 Zocor®

Eligibility Criteria

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Inclusion Criteria

* Patient is male or female 18 years of age.
* Patient is on a stable daily statin starting dose for the past 4 weeks of either: atorvastatin 10 mg or; simvastatin 20 mg
* lipid values while on statin monotherapy treatment: LDL-C level of \> 2.5 mmol/L to \* 5.0 mmol/L, triglycerides \< 4.0 mmol/L and total cholesterol \< 7.0 mmol/L.
* Patient with established coronary artery disease such as stable angina; history of myocardial infarction; history of percutaneous coronary intervention (PTCA with or without stent placement); coronary stenosis on angiography; history of unstable angina or non-Q wave myocardial infarction; history of coronary artery bypass graft surgery (CABG); positive MIBI scan. Patients have to be in a stable medical condition.

Exclusion Criteria

* Patients in whom cholesterol lowering medication regime has changed in the previous 4 weeks.
* Patients who have been treated with any other investigational drug within 3 months of Visit 1.
* Patients who are pregnant or lactating.
* Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No