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OpenTrials
Completed

NCT Number: NCT00166530

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe (+) simvastatin

Drug

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

Other names: MK0653A, Vytorin®, INEGY™

simvastatin

Drug

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

Other names: MK0733, Zocor®

atorvastatin

Drug

20 mg atorvastatin once daily for 12 weeks. Tablets

Primary outcomes

  1. Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment.

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg will lower LDL-C more than doubling the statin dose as demonstrated by the percentage change from treated baseline in total and LDL-cholesterol after 12 weeks of treatment.

    Time frame: after 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Prospective Randomized Open Label Blinded Endpoint Multicenter Study in Patients With Coronary Artery Disease to Assess the LDL Lowering Effect of Switching to Ezetimibe (+) Simvastatin for Cholesterol Lowering, Compared the Dose of the Statin Used.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 14, 2005
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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