Back to results

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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

MK0653, ezetimibe / Duration of Treatment: 6 Weeks

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00395473

First Posted

November 2, 2006

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00395473

Brief Title

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

Official Title

Ezetimibe Added to Statin Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MK0653, ezetimibe / Duration of Treatment: 6 Weeks

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

17252094

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs