NCT00130338
Completed
Phase 3
An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
ConditionsVascular Dementia
DrugsRivastigmine
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vascular Dementia
- Sponsor
- Novartis
- Enrollment
- 521
- Primary Endpoint
- Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The goal of this research study is to evaluate, in the open-label extension phase, the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate.
Exclusion Criteria
- •Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks
Outcomes
Primary Outcomes
Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
Secondary Outcomes
- 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
Similar Trials
Completed
Phase 3
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's DiseaseAlzheimer's DiseaseNCT00219232Novartis868
Recruiting
Phase 3
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)Lupus NephritisNCT06711887Novartis Pharmaceuticals315
Completed
Not Applicable
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg UlcersLeg UlcersNCT00628004Coloplast A/S93
Completed
Phase 3
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)Progressive Familial Intrahepatic Cholestasis (PFIC)NCT04185363Mirum Pharmaceuticals, Inc.90
Completed
Not Applicable
GOLO Open-Label Pilot 1Diabetes Mellitus, Type IINCT03478202Golo27