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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00166530
First received: September 9, 2005
Last updated: September 5, 2008
Last verified: September 2008

September 9, 2005
September 5, 2008
November 2005
February 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00166530 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atherosclerosis
  • Drug: ezetimibe (+) simvastatin
    Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets
    Other Names:
    • MK0653A
    • Vytorin®
    • INEGY™
  • Drug: simvastatin
    Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets
    Other Names:
    • MK0733
    • Zocor®
  • Drug: atorvastatin
    20 mg atorvastatin once daily for 12 weeks. Tablets
  • Active Comparator: 1
    Arm 1: Active comparator
    Interventions:
    • Drug: simvastatin
    • Drug: atorvastatin
  • Experimental: 2
    Arm 2: Drug
    Intervention: Drug: ezetimibe (+) simvastatin
Roeters van Lennep HW, Liem AH, Dunselman PH, Dallinga-Thie GM, Zwinderman AH, Jukema JW. The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study. Curr Med Res Opin. 2008 Mar;24(3):685-94. Epub 2008 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
Not Provided
February 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00166530
2005_059, MK0653A-089
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP