Back to resultsEfficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Primary Purpose
Vascular Dementia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivastigmine
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia focused on measuring Dementia,vascular,rivastigmine,stroke,memory loss
Eligibility Criteria
Inclusion Criteria: Between the ages of 50 and 85 years old Have contact with a responsible caregiver 3 or more days per week Be male or a female who is surgically sterilized or one year post menopausal Exclusion Criteria: Current diagnosis of severe or unstable cardiovascular or other diseases Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease
Sites / Locations
Outcomes
Primary Outcome Measures
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24
Secondary Outcome Measures
Change in activities of daily living from baseline at week 24
Change in behavioral symptoms from baseline at week 24
Change in clinical staging from baseline at week 24
Full Information
NCT ID
NCT00099216
First Posted
December 10, 2004
Last Updated
November 16, 2011
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00099216
Brief Title
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Official Title
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The goal of this research study is to evaluate 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia
Keywords
Dementia,vascular,rivastigmine,stroke,memory loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
708 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rivastigmine
Primary Outcome Measure Information:
Title
Change in cognition from baseline at week 24
Title
Global clinical impression of change from baseline at week 24
Secondary Outcome Measure Information:
Title
Change in activities of daily living from baseline at week 24
Title
Change in behavioral symptoms from baseline at week 24
Title
Change in clinical staging from baseline at week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 50 and 85 years old
Have contact with a responsible caregiver 3 or more days per week
Be male or a female who is surgically sterilized or one year post menopausal
Exclusion Criteria:
Current diagnosis of severe or unstable cardiovascular or other diseases
Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
City
Port Charlotte
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
City
Graz
Country
Austria
City
Linz
Country
Austria
City
Wien
Country
Austria
City
Edmonton
State/Province
Alberta
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Amiens
Country
France
City
Bordeaux
Country
France
City
Lille Cedex
Country
France
City
Marseille
Country
France
City
Montpellier Cedex
Country
France
City
Toulouse
Country
France
City
Tours Cedex
Country
France
City
Bautzen
Country
Germany
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Chemnitz
Country
Germany
City
Eisenhuttenstadt
Country
Germany
City
Erlangen
Country
Germany
City
Freiburg
Country
Germany
City
Luedenscheid
Country
Germany
City
Osnabrueck
Country
Germany
City
Ancona
Country
Italy
City
Brescia
Country
Italy
City
Firenze
Country
Italy
City
Perugia
Country
Italy
City
Reggio Emilia
Country
Italy
City
Roma
Country
Italy
City
Vicenza
Country
Italy
City
Moscow
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Barakaldo
Country
Spain
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Pamplona
Country
Spain
City
Saint Cugat del Valles
Country
Spain
City
Basel
Country
Switzerland
City
Lausanne
Country
Switzerland
City
Newcastle Upon Tyne
State/Province
Newcastle
Country
United Kingdom
City
Swindon
State/Province
Wiltshire
Country
United Kingdom
City
Bristol
Country
United Kingdom
City
Clydebank
Country
United Kingdom
City
East Sussex
Country
United Kingdom
City
Southampton
Country
United Kingdom
City
St Annes
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18674411
Citation
Ballard C, Sauter M, Scheltens P, He Y, Barkhof F, van Straaten EC, van der Flier WM, Hsu C, Wu S, Lane R. Efficacy, safety and tolerability of rivastigmine capsules in patients with probable vascular dementia: the VantagE study. Curr Med Res Opin. 2008 Sep;24(9):2561-74. doi: 10.1185/03007990802328142. Epub 2008 Jul 31.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=331&diseaseID=31zip=07430
Description
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Learn more about this trial
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
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