Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Recruitment postcode(s) [3] 0 0
- Hornsby Streets
Recruitment postcode(s) [4] 0 0
- 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Austria
State/province [26] 0 0
Graz N/A
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Belgium
State/province [29] 0 0
Aalst
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerpen
Country [31] 0 0
Belgium
State/province [31] 0 0
Hasselt
Country [32] 0 0
Belgium
State/province [32] 0 0
Jumet
Country [33] 0 0
Belgium
State/province [33] 0 0
Leuven
Country [34] 0 0
Belgium
State/province [34] 0 0
Liege
Country [35] 0 0
Belgium
State/province [35] 0 0
Merksem
Country [36] 0 0
Belgium
State/province [36] 0 0
Reet
Country [37] 0 0
Belgium
State/province [37] 0 0
Roeselare
Country [38] 0 0
Belgium
State/province [38] 0 0
Wilrijk
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
New Brunswick
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Canada
State/province [45] 0 0
Saskatchewan
Country [46] 0 0
Canada
State/province [46] 0 0
London N/A
Country [47] 0 0
Canada
State/province [47] 0 0
Montreal N/A
Country [48] 0 0
Canada
State/province [48] 0 0
North York
Country [49] 0 0
Canada
State/province [49] 0 0
T2n
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Chomutov N/A
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Dobrany N/A
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Hluboká Nad Vltavou
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Kolín 2
Country [54] 0 0
Czech Republic
State/province [54] 0 0
Opava
Country [55] 0 0
Czech Republic
State/province [55] 0 0
Praha 8 N/A
Country [56] 0 0
Czech Republic
State/province [56] 0 0
Rennes Cedex
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Usti Nad Labem N/A
Country [58] 0 0
Finland
State/province [58] 0 0
Helsinki
Country [59] 0 0
Finland
State/province [59] 0 0
Kuopio N/A
Country [60] 0 0
France
State/province [60] 0 0
Toulouse
Country [61] 0 0
Germany
State/province [61] 0 0
Berlin
Country [62] 0 0
Germany
State/province [62] 0 0
Frankfurt Am Main
Country [63] 0 0
Germany
State/province [63] 0 0
Mannheim
Country [64] 0 0
Germany
State/province [64] 0 0
München
Country [65] 0 0
Germany
State/province [65] 0 0
Nürnberg
Country [66] 0 0
Germany
State/province [66] 0 0
Ulm
Country [67] 0 0
Israel
State/province [67] 0 0
Haifa
Country [68] 0 0
Israel
State/province [68] 0 0
Petach Tikya
Country [69] 0 0
Israel
State/province [69] 0 0
Ramat Gan
Country [70] 0 0
Israel
State/province [70] 0 0
Tel Aviv
Country [71] 0 0
Netherlands
State/province [71] 0 0
'S-Hertogenbosch
Country [72] 0 0
Netherlands
State/province [72] 0 0
Alkmaar
Country [73] 0 0
Netherlands
State/province [73] 0 0
Amsterdam
Country [74] 0 0
Netherlands
State/province [74] 0 0
Breda
Country [75] 0 0
Netherlands
State/province [75] 0 0
Maastricht
Country [76] 0 0
Poland
State/province [76] 0 0
Gdansk
Country [77] 0 0
Poland
State/province [77] 0 0
Katowice Poland
Country [78] 0 0
Poland
State/province [78] 0 0
Lodz N/A
Country [79] 0 0
Poland
State/province [79] 0 0
Mosina Poland
Country [80] 0 0
Poland
State/province [80] 0 0
Poznan N/A
Country [81] 0 0
Poland
State/province [81] 0 0
Poznan Poland
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Spain
State/province [83] 0 0
Barakaldo Vizcaya S/N
Country [84] 0 0
Spain
State/province [84] 0 0
Barcelona N/A
Country [85] 0 0
Spain
State/province [85] 0 0
Madrid
Country [86] 0 0
Spain
State/province [86] 0 0
Terrasa Barcelona N/A
Country [87] 0 0
Sweden
State/province [87] 0 0
Linköping
Country [88] 0 0
Sweden
State/province [88] 0 0
Lund N/A
Country [89] 0 0
Sweden
State/province [89] 0 0
Malmö
Country [90] 0 0
Sweden
State/province [90] 0 0
Mölndal N/A
Country [91] 0 0
Sweden
State/province [91] 0 0
Piteå
Country [92] 0 0
Sweden
State/province [92] 0 0
Stockholm
Country [93] 0 0
Sweden
State/province [93] 0 0
Umeå
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Bradford
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Bristol
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Clydebank
Country [97] 0 0
United Kingdom
State/province [97] 0 0
New Milton
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Southampton
Country [99] 0 0
United Kingdom
State/province [99] 0 0
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