NCT Number: NCT00000483
Coronary Drug Project Mortality Surveillance
To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
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Conditions
Age range
30 year–64 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
About this study
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 Query/View/Report (QVR) System.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
No eligibility criteria
Treatment and study plan
clofibrate
Drugdextrothyroxine sodium
Drugniacin
DrugSponsors and collaborators
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Nih
Registry information
Important dates
- Study start
- 1981
- Study completion
- 1985
- First posted
- Oct 28, 1999
- Registry last updated
- Nov 26, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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