Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg (EXPLORER)
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ClinicalTrials.gov Identifier: NCT00653445 |
Recruitment Status :
Completed
First Posted : April 7, 2008
Last Update Posted : March 26, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia Coronary Heart Disease Atherosclerosis | Drug: Rosuvastatin Drug: Ezetimibe | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | June 2004 |
Actual Study Completion Date : | June 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
|
Drug: Rosuvastatin
40mg
Other Name: Crestor Drug: Ezetimibe 10mg
Other Name: Zetia |
Experimental: 2
Rosuvastatin 40 mg
|
Drug: Rosuvastatin
40mg
Other Name: Crestor |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)..

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653445
Principal Investigator: | Christine Ballantyne, MD | Centre for prevention of cardiovascular disease, Texas, USA |
Responsible Party: | Elisabeth Björk, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00653445 |
Other Study ID Numbers: |
D3569C00006 |
First Posted: | April 7, 2008 Key Record Dates |
Last Update Posted: | March 26, 2009 |
Last Verified: | March 2009 |
Low density lipoproteins Hypercholesterolemia Coronary Heart Disease |
Rosuvastatin Crestor Ezetimibe |
Heart Diseases Atherosclerosis Coronary Disease Coronary Artery Disease Myocardial Ischemia Hypercholesterolemia Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin Calcium Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |