- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00130338
Rivastigmine Capsules in Patients With Probable Vascular Dementia
March 24, 2017 updated by: Novartis
An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
521
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
|
Secondary Outcome Measures
Outcome Measure |
---|
52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
August 11, 2005
First Submitted That Met QC Criteria
August 11, 2005
First Posted (Estimate)
August 15, 2005
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Dementia, Vascular
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Cholinesterase Inhibitors
- Rivastigmine
Other Study ID Numbers
- CENA713BIA05E1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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