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OpenTrials
Completed

NCT Number: NCT00395473

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0653, ezetimibe / Duration of Treatment: 6 Weeks

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Ezetimibe Added to Statin Therapy

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Nov 3, 2006
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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