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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 14, 2008 | ||||
| Last Updated Date | August 5, 2008 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Percentage of patients treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00622713 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA) | ||||
| Official Title ICMJE | A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26) | ||||
| Brief Summary | This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Alzheimer's Disease | ||||
| Intervention ICMJE | Drug: Rivastigmine transdermal patch | ||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | December 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. |
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00622713 | ||||
| Responsible Party | External Affairs, Novartis | ||||
| Study ID Numbers ICMJE | CENA713DFRO8, N° EudraCT : 2007-003405-27 | ||||
| Study Sponsor ICMJE | Novartis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | August 2008 | ||||
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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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