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

Hypercholesterolemia Clinical Trial

Official title:

Ezetimibe Added to Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395473
• Other study ID #: 0653-087
• Secondary ID: 2006_041
• Status: Completed
• Phase: Phase 3
• Start date: March 2005
• Est. completion date: November 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment