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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
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- 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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Cordoba
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00297414