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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: MK0653, ezetimibe / Duration of Treatment: 6 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395473

0653-087

2006_041

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)