Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis
Intervention: Rosuvastatin (Drug); Ezetimibe (Drug)
Phase: Phase 3
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
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.
- 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.
- 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)..
Locations and Contacts
Starting date: June 2004
Ending date: September 2005
Last updated: April 4, 2008