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| Tracking Information | |||||
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| First Received Date ICMJE | October 16, 2005 | ||||
| Last Updated Date | October 16, 2005 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Determine the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide ventriculography, at 26 weeks post randomization from baseline. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines | ||||
| Official Title ICMJE | A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Assess the Impact of Rosuvastatin Treatment for 26 Weeks (Titrated to a Maximum Dose of 40mg Once Daily) on Left Ventricular Function, Cytokines and Lipid Parameters in Patients With Established Systolic Chronic Heart Failure. | ||||
| Brief Summary | The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide ventriculography, at 26 weeks post randomisation from baseline. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Heart Failure, Congestive | ||||
| Intervention ICMJE | Drug: Rosuvastatin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 160 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00240292 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 4522AS/0002 | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | October 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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