Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000483
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Coronary Drug Project Mortality Surveillance
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-04
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:
To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project estrogens dextrothyroxine nicotinic acid clofibrate
Detailed Description:
BACKGROUND
Three of the CDP treatments two doses of estrogen and dextrothyroxine were stopped prematurely because of toxicity At the time the treatments were stopped it was thought that future assessment of the status of patients on those treatments would be important to evaluate long-term sequellae Another clinical trial evaluating clofibrate for primary prevention found that more patients on that treatment than on placebo had died This effect persisted even after the treatment was stopped Therefore it was considered necessary to follow the CDP patients on clofibrate
Of the original 834l patients about 6000 were still alive in March l975 Cause-specific mortality in those patients was assessed through March l980
DESIGN NARRATIVE
The vital status of the subjects known to be alive at the end of the CDP in March l975 was assessed as of March l980 This was accomplished through questioning the local investigators letters to the subjects and by use of Social Security Administration and National Death Index records
The study completion date listed in this record was obtained from the QueryViewReport QVR System
Three of the CDP treatments two doses of estrogen and dextrothyroxine were stopped prematurely because of toxicity At the time the treatments were stopped it was thought that future assessment of the status of patients on those treatments would be important to evaluate long-term sequellae Another clinical trial evaluating clofibrate for primary prevention found that more patients on that treatment than on placebo had died This effect persisted even after the treatment was stopped Therefore it was considered necessary to follow the CDP patients on clofibrate
Of the original 834l patients about 6000 were still alive in March l975 Cause-specific mortality in those patients was assessed through March l980
DESIGN NARRATIVE
The vital status of the subjects known to be alive at the end of the CDP in March l975 was assessed as of March l980 This was accomplished through questioning the local investigators letters to the subjects and by use of Social Security Administration and National Death Index records
The study completion date listed in this record was obtained from the QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL008888-14S1 | OTHER_GRANT | US NIH Grant Number | None |