Status:

COMPLETED

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

Lead Sponsor:

Organon and Co

Conditions:

Atherosclerosis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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 t...

Detailed Description

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 pl...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2007

Estimated Enrollment :

367 Patients enrolled

Trial Details

Trial ID

NCT00166530

Start Date

November 1 2005

End Date

February 1 2007

Last Update

August 15 2024

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