Coronary Drug Project Mortality Surveillance
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| First Received Date ICMJE | October 27, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | June 1981 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00000483 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Coronary Drug Project Mortality Surveillance | ||||
| Official Title ICMJE | Not Provided | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | 30 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00000483 | ||||
| Other Study ID Numbers ICMJE | 2 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | April 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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