Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1981-06-30
1985-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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estrogen
clofibrate
dextrothyroxine sodium
niacin
Eligibility Criteria
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Inclusion Criteria
30 Years
64 Years
MALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Principal Investigators
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Roger Sherwin
Role:
University of Maryland
References
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Canner PL, Klimt CR. The Coronary Drug Project. Experimental design features. Control Clin Trials. 1983 Dec;4(4):313-32. doi: 10.1016/0197-2456(83)90019-3. No abstract available.
Canner PL, Stamler J. The Coronary Drug Project. Organizational structure of the study. Control Clin Trials. 1983 Dec;4(4):333-43. doi: 10.1016/0197-2456(83)90020-x. No abstract available.
Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986 Dec;8(6):1245-55. doi: 10.1016/s0735-1097(86)80293-5.
Berge KG, Canner PL. Coronary drug project: experience with niacin. Coronary Drug Project Research Group. Eur J Clin Pharmacol. 1991;40 Suppl 1:S49-51.
Other Identifiers
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R01HL008888-14S1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2
Identifier Type: -
Identifier Source: org_study_id