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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: November 2, 2006
Last updated: January 19, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Drug: MK0653, ezetimibe / Duration of Treatment: 6 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ezetimibe Added to Statin Therapy

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment

Enrollment: 141
Study Start Date: March 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00395473

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00395473     History of Changes
Other Study ID Numbers: 0653-087  2006_041 
Study First Received: November 2, 2006
Last Updated: January 19, 2016
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016