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Clinical Trials/NCT00130338
NCT00130338
Completed
Phase 3

An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Novartis0 sites521 target enrollmentFebruary 2002

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.

Registry
clinicaltrials.gov
Start Date
February 2002
End Date
May 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

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

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