Back to resultsCompare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg (EXPLORER)
Primary Purpose
Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Ezetimibe
Eligibility 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)..
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
Rosuvastatin 40 mg
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00653445
Brief Title
Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
Acronym
EXPLORER
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
Keywords
Low density lipoproteins, Hypercholesterolemia, Coronary Heart Disease, Rosuvastatin, Crestor, Ezetimibe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Rosuvastatin 40 mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
40mg
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia
Intervention Description
10mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
Title
Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Ballantyne, MD
Organizational Affiliation
Centre for prevention of cardiovascular disease, Texas, USA
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
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