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

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00395473
• Lead Sponsor: Organon and Co

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 more.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-02
• Study First Posted: 2006-11-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment