Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
1 other identifier
interventional
708
10 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2001
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedNovember 17, 2011
November 1, 2011
4.3 years
December 10, 2004
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in cognition from baseline at week 24
Global clinical impression of change from baseline at week 24
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current diagnosis of severe or unstable cardiovascular or other diseases
- Current diagnosis of active, uncontrolled seizure disorder, Parkinson's disease or Alzheimer's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Unknown Facility
Irvine, California, 92618, United States
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San Francisco, California, 94109, United States
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Boynton Beach, Florida, 33426, United States
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Miami Beach, Florida, 33140, United States
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Port Charlotte, Florida, United States
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Indianapolis, Indiana, 46202, United States
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Des Moines, Iowa, 50314, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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New York, New York, 10003, United States
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Portland, Oregon, 97223, United States
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Allentown, Pennsylvania, 18103, United States
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Greensburg, Pennsylvania, 15601, United States
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Charleston, South Carolina, 29406, United States
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Austin, Texas, 78756, United States
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Houston, Texas, 77030, United States
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Bennington, Vermont, 05201, United States
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Graz, Austria
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Linz, Austria
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Vienna, Austria
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Edmonton, Alberta, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Amiens, France
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Bordeaux, France
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Lille, France
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Marseille, France
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Montpellier, France
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Toulouse, France
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Tours, France
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Bautzen, Germany
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Berlin, Germany
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Bochum, Germany
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Chemnitz, Germany
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Eisenhüttenstadt, Germany
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Erlangen, Germany
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Freiburg im Breisgau, Germany
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Lüdenscheid, Germany
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Osnabrück, Germany
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Ancona, Italy
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Brescia, Italy
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Florence, Italy
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Perugia, Italy
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Reggio Emilia, Italy
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Roma, Italy
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Vicenza, Italy
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Moscow, Russia
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Saint Petersburg, Russia
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Barakaldo, Spain
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Barcelona, Spain
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Madrid, Spain
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Pamplona, Spain
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Saint Cugat Del Valles, Spain
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Basel, Switzerland
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Lausanne, Switzerland
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Newcastle upon Tyne, Newcastle, United Kingdom
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Swindon, Wiltshire, United Kingdom
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Bristol, United Kingdom
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Clydebank, United Kingdom
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East Sussex, United Kingdom
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Lytham St Annes, United Kingdom
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Southampton, United Kingdom
Related Publications (1)
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.
PMID: 18674411DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2004
First Posted
December 10, 2004
Study Start
August 1, 2001
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
November 17, 2011
Record last verified: 2011-11