Status:

COMPLETED

Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

Lead Sponsor:

AstraZeneca

Conditions:

Hypercholesterolemia

Coronary Heart Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein lev...

Eligibility Criteria

Inclusion

  • A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
  • Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
  • Discontinuation of all lipid lowering therapy at Visit 1.

Exclusion

  • History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
  • Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
  • Severe congestive cardiac failure (as defined by the protocol - Appendix I).
  • Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

End Date :

June 1 2005

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00653445

Start Date

June 1 2004

End Date

June 1 2005

Last Update

March 26 2009

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