Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

NCT ID: NCT00099216

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vascular Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rivastigmine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Irvine, California, United States

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San Francisco, California, United States

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Boynton Beach, Florida, United States

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Miami Beach, Florida, United States

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Port Charlotte, Florida, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, 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, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Greensburg, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Bennington, Vermont, 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

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Countries

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United States Austria Canada France Germany Italy Russia Spain Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 18674411 (View on PubMed)

Related Links

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http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=331&diseaseID=31zip=07430

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Other Identifiers

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CENA713BIA05

Identifier Type: -

Identifier Source: org_study_id