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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment
Secondary ID [1] 0 0
GAL-COG-3002
Secondary ID [2] 0 0
CR004240
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate vital status of patients enrolled in 3 galantamine studies
Timepoint [1] 0 0
4 weeks

Eligibility
Key inclusion criteria
* All patients who were randomized and treated with galantamine or placebo in 3 previous studies (CR003145, CR002014, and CR005947)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients not enrolled in above referenced studies

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2005
Sample size
Target
Accrual to date
Final
1083
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Christchurch Nz
Recruitment hospital [3] 0 0
- Hornsby Streets
Recruitment hospital [4] 0 0
- Kew
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Perth
Recruitment hospital [7] 0 0
- Randwick
Recruitment hospital [8] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Christchurch Nz
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- Hornsby Streets
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- Kew
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Randwick
Recruitment postcode(s) [8] 0 0
- Woodville
Recruitment outside Australia
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Arizona
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California
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Connecticut
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Argentina
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Cordoba
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Graz N/A
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Innsbruck
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Hasselt
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Ramat Gan
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'S-Hertogenbosch
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Breda
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Maastricht
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Gdansk
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Lund N/A
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Umeå
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Bradford
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Bristol
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Clydebank
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New Milton
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Southampton
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United Kingdom
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Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00297414
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, LLC C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00297414