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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00297414
Registration number
NCT00297414
Ethics application status
Date submitted
24/02/2006
Date registered
28/02/2006
Date last updated
12/04/2012
Titles & IDs
Public title
An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine
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Scientific title
An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment
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Secondary ID [1]
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GAL-COG-3002
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Secondary ID [2]
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CR004240
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment
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Condition category
Condition code
Mental Health
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0
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No intervention
Patients with mild cognitive impairment - Patients with mild cognitive impairment who were treated with galantamine or placebo in previous 3 clinical studies.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate vital status of patients enrolled in 3 galantamine studies
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Assessment method [1]
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Poststudy vital status (living or deceased) of patients who participated in 3 clinical studies with galantamine will be evaluated. Data will be collected as vital status of the patient, date of death, cause of death and adverse events associated with death.
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Timepoint [1]
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4 weeks
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Eligibility
Key inclusion criteria
- All patients who were randomized and treated with galantamine or placebo in 3 previous
studies (CR003145, CR002014, and CR005947)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients not enrolled in above referenced studies
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2004
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2005
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Sample size
Target
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Accrual to date
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Final
1083
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Recruitment in Australia
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- Adelaide
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- Christchurch Nz
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- Hornsby Streets
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- Kew
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- Parkville
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- Randwick
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- Woodville
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- Adelaide
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- Christchurch Nz
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- Hornsby Streets
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- Kew
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- Parkville
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- Perth
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- Randwick
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- Woodville
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Funding & Sponsors
Primary sponsor type
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Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00297414
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial
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Address
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00297414
Download to PDF