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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00166530 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)
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Scientific title:
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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. |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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367 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00166530 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atherosclerosis
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Intervention(s)
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Drug: atorvastatin
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Drug: ezetimibe (+) simvastatin
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Drug: simvastatin
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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2005_059
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MK0653A-089
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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