Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)
2 other identifiers
interventional
141
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2005
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 2, 2006
CompletedFirst Posted
Study publicly available on registry
November 3, 2006
CompletedMay 10, 2024
February 1, 2022
8 months
November 2, 2006
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related 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.
PMID: 17252094BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2006
First Posted
November 3, 2006
Study Start
March 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
May 10, 2024
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share