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

NCT00166530 | Completed Phase 4

• 3 other identifiers: 0653A-089MK0653A-0892005_059
• Study Type: interventional
• Target: 367
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Atherosclerosis

Outcome Measures

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.

  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.

  after 12 weeks of treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: Active comparator

Drug: simvastatin; Drug: atorvastatin

2

EXPERIMENTAL

Arm 2: Drug

Drug: ezetimibe (+) simvastatin

Interventions

ezetimibe (+) simvastatin DRUG

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

Also known as: MK0653A, Vytorin®, INEGY™

2

simvastatin DRUG

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

Also known as: MK0733, Zocor®

1

atorvastatin DRUG

20 mg atorvastatin once daily for 12 weeks. Tablets

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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. doi: 10.1185/030079908X273273. Epub 2008 Jan 25.

  PMID: 18226326 DERIVED

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Conditions

Atherosclerosis

Interventions

Ezetimibe, Simvastatin Drug Combination; Simvastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 15, 2024

Record last verified: 2022-02