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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00166530

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis	Drug: ezetimibe (+) simvastatin Drug: simvastatin Drug: atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official 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.

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Statins

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Ezetimibe Vytorin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	367
Study Start Date:	November 2005
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Arm 1: Active comparator	Drug: simvastatin Zocor®; simvastatin 40 mg once daily for 12 weeks. Tablets Drug: atorvastatin 20 mg atorvastatin once daily for 12 weeks. Tablets
2: Experimental Arm 2: Drug	Drug: ezetimibe (+) simvastatin Vytorin® combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. Tablets

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 plus simvastatin 20 mg once daily for 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166530

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_059, MK0653A-089
Study First Received:	September 9, 2005
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00166530 History of Changes
Health Authority:	Netherlands: Medicines Evaluation Board (MEB)

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Myocardial Ischemia
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Ezetimibe
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Cardiovascular Diseases
Coronary Artery Disease
Atorvastatin

ClinicalTrials.gov processed this record on November 20, 2009