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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653445
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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 level goals.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Coronary Heart Disease Atherosclerosis Drug: Rosuvastatin Drug: Ezetimibe Phase 3

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
  2. Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)..
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Christine Ballantyne, MD Centre for prevention of cardiovascular disease, Texas, USA
More Information
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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
Keywords provided by AstraZeneca:
Low density lipoproteins
Hypercholesterolemia
Coronary Heart Disease
 Rosuvastatin
Crestor
Ezetimibe
Additional relevant MeSH terms:
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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