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

Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

Intervention: Rosuvastatin (Drug); Ezetimibe (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christine Ballantyne, MD, Principal Investigator, Affiliation: Centre for prevention of cardiovascular disease, Texas, USA

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.

Official title: A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).

Study design: Treatment, Randomized, Open Label, Parallel Assignment

Primary outcome: To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6

Secondary outcome:

To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6

Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)..

Starting date: June 2004
Ending date: September 2005
Last updated: April 4, 2008