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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00549601 |
This study will use two doses of rivastigmine transdermal patch (5cm2, 10cm2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3mg/bid, 4,5mg/bid, 6mg/bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience and caregivers preferences of rivastigmine transdermal patch versus capsules.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: rivastigmine transdermal patch Drug: rivastigmine capsules |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Feasibility of the Switch From Rivastigmine Capsules to Rivastigmine Transdermal Patch: Randomized, Open Label, Controlled Multicenter Study |
Estimated Enrollment: | 144 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: rivastigmine transdermal patch |
2: Experimental | Drug: rivastigmine transdermal patch |
3: Active Comparator | Drug: rivastigmine capsules |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taken any of the following substances prior to randomization:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis Pharmaceuticals | +41 61 324 1111 |
Spain | |
Novartis Investigative Site | Recruiting |
Barcelona, Spain |
Study Director: | Novartis Pharmaceuticals, MD | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CENA713DES07 |
Study First Received: | October 24, 2007 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00549601 |
Health Authority: | Spain: Agencia Española del Medicamento |
Alzheimer's rivastigmine transdermal safety |
randomized switch patch |
Delirium, Dementia, Amnestic, Cognitive Disorders Rivastigmine Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Cholinergic Agents Neuroprotective Agents |
Protective Agents Pharmacologic Actions Cholinesterase Inhibitors Therapeutic Uses Tauopathies Central Nervous System Agents |