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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653445
First Posted: April 7, 2008
Last Update Posted: March 26, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Hypercholesterolemia Coronary Heart Disease Atherosclerosis Drug: Rosuvastatin Drug: Ezetimibe Phase 3

Study Type: Interventional
Study Design: 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%).

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

Study Start Date: June 2004
Study Completion Date: June 2005
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Principal Investigator: Christine Ballantyne, MD Centre for prevention of cardiovascular disease, Texas, USA
  More Information

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00653445     History of Changes
Other Study ID Numbers: D3569C00006
First Submitted: April 2, 2008
First Posted: April 7, 2008
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:
Heart Diseases
Atherosclerosis
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
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