An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine

NCT ID: NCT00297414

Last Updated: 2012-04-12

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

Total Enrollment

1083 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-01-31

Brief Summary

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The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

Detailed Description

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The objective of this observational study is to ascertain follow-up vital status data for patients who were randomized (assignment of study medication by chance) and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014 and CR005947). This study is designed to evaluate the imbalance of deaths that were initially recorded in the double-blind (neither physician nor patient knows the treatment that the patient receives) phases of two of these studies. Data will be combined from three sources: the databases of the 3 previous studies, forms from investigators, and data acquired during the present study. Investigator will obtain consent from the patients or their informant for participating in the study. Data on vital status will be obtained either from the patient or informant after obtaining informed consent. If a patient does not provide informed consent, documentation of contact with the patient will suffice as evidence that the patient is alive. If an informant does not provide informed consent or a patient cannot be contacted, medical or death records or death registers will be consulted when necessary to determine if a death occurred. If a patient was found to have died, the investigator records the cause of death, date of death, and the adverse events (unwanted consequence that occurs during the course of the clinical study, but not necessarily because of study medication) leading to death, by a review of medical records, autopsy records, and/or death certificates.

Conditions

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Mild Cognitive Impairment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with mild cognitive impairment

Patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

No intervention

Intervention Type OTHER

No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

Interventions

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No intervention

No study drug was administered to the patients. Data on vital status was obtained for patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients who were randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)

Exclusion Criteria

* Patients not enrolled in above referenced studies
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Janssen R&D US

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

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Tucson, Arizona, United States

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Laguna Woods, California, United States

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Northridge, California, United States

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Oceanside, California, United States

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Paramount, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Hamden, Connecticut, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Oscala F, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Paducah, Kentucky, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Kalamazoo, Michigan, United States

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Clementon, New Jersey, United States

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Ridgewood, New Jersey, United States

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Summit, New Jersey, United States

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Albany, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Wichita Falls, Texas, United States

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Bennington, Vermont, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Middleton, Wisconsin, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Adelaide, , Australia

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Christchurch Nz, , Australia

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Hornsby Streets, , Australia

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Kew, , Australia

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Parkville, , Australia

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Perth, , Australia

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Randwick, , Australia

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Woodville, , Australia

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Graz, , Austria

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Innsbruck, , Austria

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Vienna, , Austria

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Aalst, , Belgium

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Antwerp, , Belgium

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Hasselt, , Belgium

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Jumet, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Merksem, , Belgium

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Reet, , Belgium

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Roeselare, , Belgium

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Wilrijk, , Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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North York, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Verdun, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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London, , Canada

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Montreal, , Canada

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North York, , Canada

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T2n, , Canada

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Chomutov, , Czechia

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Dobřany, , Czechia

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Hluboká nad Vltavou, , Czechia

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Kolín, , Czechia

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Opava, , Czechia

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Praha 8 N/A, , Czechia

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Rennes Cedex, , Czechia

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Ústí nad Labem, , Czechia

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Helsinki, , Finland

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Kuopio, , Finland

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Toulouse, , France

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Berlin, , Germany

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Frankfurt am Main, , Germany

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Mannheim, , Germany

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München, , Germany

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Nuremberg, , Germany

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Ulm, , Germany

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Haifa, , Israel

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Petach Tikya, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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's-Hertogenbosch, , Netherlands

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Alkmaar, , Netherlands

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Amsterdam, , Netherlands

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Breda, , Netherlands

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Maastricht, , Netherlands

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Gdansk, , Poland

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Katowice Poland, , Poland

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Lodz, , Poland

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Mosina Poland, , Poland

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Poznan, , Poland

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Poznan Poland, , Poland

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Warsaw, , Poland

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Barakaldo Vizcaya S/N, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Terrasa Barcelona N/A, , Spain

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Linköping, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Mölndal, , Sweden

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Piteå, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Bradford, , United Kingdom

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Bristol, , United Kingdom

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Clydebank, , United Kingdom

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New Milton, , United Kingdom

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Southampton, , United Kingdom

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Swindon, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Canada Czechia Finland France Germany Israel Netherlands Poland Spain Sweden United Kingdom

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=573&filename=CR004240_CSR.pdf

Survey of the vital status of patients who participated in three studies of galantamine in treatment of mild cognitive impairment.

Other Identifiers

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GAL-COG-3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR004240

Identifier Type: -

Identifier Source: org_study_id

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