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

NCT ID: NCT00395473

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2005-11-30

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MK0653, ezetimibe / Duration of Treatment: 6 Weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Simons LA, Symons J. Ezetimibe added to statin therapy (EASY study) - an evaluation by Australian general practitioners. Aust Fam Physician. 2007 Jan-Feb;36(1-2):90-2, 96.

Reference Type: BACKGROUND

PMID: 17252094 (View on PubMed)

Other Identifiers

2006_041

Identifier Type: -

Identifier Source: secondary_id

0653-087

Identifier Type: -

Identifier Source: org_study_id