Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297414
Status:
COMPLETED
Last Update Posted:
2012-04-12
First Post:
2006-02-24
Brief Title:
An Observational Study for Analysis of Mortality in Participants Who Participated in Previous 3 Studies of Galantamine
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 andor death certificates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GAL-COG-3002 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |