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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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 level goals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)..