Ezetimibe Added to Statin Therapy
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.
Status: Completed (Phase 3). Started on March 1st, 2005.
Enrollment: 141 subjects
Study Type: Interventional
Study Design:
- Treatment
- Non-Randomized
- Open Label
- Uncontrolled
- Single Group Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Drug: MK0653, ezetimibe / Duration of Treatment: 6 Weeks
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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Merck
Authority: Australia: National Health and Medical Research Council
Officials
Medical Monitor (Study Director, Merck)
Sponsors
Merck (Lead Sponsor)
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.
PMID: 17252094.
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Links
None.
- Date Verified
- May 1st, 2007
- First Received
- May 17th, 2007
- Last Changed
- May 17th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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