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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00395473
First received: November 2, 2006
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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
Hypercholesterolemia
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
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
ClinicalTrials.gov Identifier: NCT00395473     History of Changes
Other Study ID Numbers: 2006_041
Study First Received: November 2, 2006
Last Updated: May 24, 2013
Health Authority: Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on August 28, 2014