Status:
COMPLETED
Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or mo...
Eligibility Criteria
Inclusion
- Patients who will remain on a stable statin dose of 40mg or more, for the duration of the study
- Patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin
Exclusion
- Illnesses such as congestive heart failure nyha class iii or iv
- Uncontrolled hypertension
- Myocardial infarction
- Coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit
- Unstable angina pectoris or unstable or severe peripheral vascular disease
- Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled
- Serum creatinine \>0.18mmol/l at enrolment or active renal disease with significant proteinuria
- Disorders of the haematologic, digestive (including malabsorptive disorders)
- Central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation
- Active acute or chronic hepatobiliary disease
- Patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin
- Tg \>4.0mmol/l while using a statin
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00395473
Start Date
March 1 2005
End Date
November 1 2005
Last Update
May 10 2024
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