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| Tracking Information | |||||
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| First Received Date ICMJE | August 31, 2005 | ||||
| Last Updated Date | January 5, 2006 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Composite endpoint including cardiovascular mortality, hospitalisation for acute myocardial infarction and for new onset or worsening heart failure. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00143507 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Composite and non-composite endpoints including hospitalisation for acute coronary syndrome, coronary revascularisation and mortality. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction | ||||
| Official Title ICMJE | Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-Year Randomised Double-Blind Placebo-Controlled International Multicentre Study. | ||||
| Brief Summary | The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Randomized, Double-Blind, Placebo Control, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Ivabradine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. Epub 2008 Aug 29. | ||||
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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 | Recruiting | ||||
| Enrollment ICMJE | 10000 | ||||
| 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 |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00143507 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CL3-16257-056 | ||||
| Study Sponsor ICMJE | Institut De Recherche International Servier | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Servier | ||||
| Verification Date | September 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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