Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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 more.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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