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

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ClinicalTrials.gov Identifier: NCT00395473
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: MK0653, ezetimibe / Duration of Treatment: 6 Weeks Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ezetimibe Added to Statin Therapy
Study Start Date : March 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe
U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395473


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00395473     History of Changes
Other Study ID Numbers: 0653-087
2006_041
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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