Nctid:
NCT00000483
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D006331", "term"=>"Heart Diseases"}, {"id"=>"D009203", "term"=>"Myocardial Infarction"}, {"id"=>"D003327", "term"=>"Coronary Disease"}, {"id"=>"D017202", "term"=>"Myocardial Ischemia"}, {"id"=>"D007238", "term"=>"Infarction"}], "ancestors"=>[{"id"=>"D007511", "term"=>"Ischemia"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D009336", "term"=>"Necrosis"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}], "browseLeaves"=>[{"id"=>"M9419", "name"=>"Heart Diseases", "asFound"=>"Heart Disease", "relevance"=>"HIGH"}, {"id"=>"M6549", "name"=>"Coronary Disease", "asFound"=>"Coronary Disease", "relevance"=>"HIGH"}, {"id"=>"M6546", "name"=>"Coronary Artery Disease", "relevance"=>"LOW"}, {"id"=>"M19506", "name"=>"Myocardial Ischemia", "asFound"=>"Myocardial Ischemia", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M12155", "name"=>"Myocardial Infarction", "asFound"=>"Myocardial Infarction", "relevance"=>"HIGH"}, {"id"=>"M10282", "name"=>"Infarction", "asFound"=>"Infarction", "relevance"=>"HIGH"}, {"id"=>"M12284", "name"=>"Necrosis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D009525", "term"=>"Niacin"}, {"id"=>"D002994", "term"=>"Clofibrate"}, {"id"=>"D004967", "term"=>"Estrogens"}], "ancestors"=>[{"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000960", "term"=>"Hypolipidemic Agents"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D057847", "term"=>"Lipid Regulating Agents"}, {"id"=>"D014665", "term"=>"Vasodilator Agents"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}, {"id"=>"D000924", "term"=>"Anticholesteremic Agents"}], "browseLeaves"=>[{"id"=>"M12476", "name"=>"Niacinamide", "relevance"=>"LOW"}, {"id"=>"M12465", "name"=>"Niacin", "asFound"=>"Reserve", "relevance"=>"HIGH"}, {"id"=>"M12479", "name"=>"Nicotinic Acids", "relevance"=>"LOW"}, {"id"=>"M8116", "name"=>"Estrogens", "asFound"=>"Amoxicillin", "relevance"=>"HIGH"}, {"id"=>"M6226", "name"=>"Clofibrate", "asFound"=>"Factor B", "relevance"=>"HIGH"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M4278", "name"=>"Hypolipidemic Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M28883", "name"=>"Lipid Regulating Agents", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"M4243", "name"=>"Anticholesteremic Agents", "relevance"=>"LOW"}, {"id"=>"T455", "name"=>"Nicotinamide", "relevance"=>"LOW"}, {"id"=>"T453", "name"=>"Niacin", "asFound"=>"Reserve", "relevance"=>"HIGH"}, {"id"=>"T454", "name"=>"Niacinamide", "relevance"=>"LOW"}, {"id"=>"T456", "name"=>"Nicotinic Acid", "relevance"=>"LOW"}, {"id"=>"T471", "name"=>"Vitamin B3", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Lipid Regulating Agents", "abbrev"=>"Lipd"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"PREVENTION"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1981-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-04", "completionDateStruct"=>{"date"=>"1985-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-11-25", "studyFirstSubmitDate"=>"1999-10-27", "studyFirstSubmitQcDate"=>"1999-10-27", "lastUpdatePostDateStruct"=>{"date"=>"2013-11-26", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-10-28", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Cardiovascular Diseases", "Coronary Disease", "Heart Diseases", "Myocardial Infarction", "Myocardial Ischemia"]}, "referencesModule"=>{"references"=>[{"pmid"=>"6675887", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"6675888", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"3782631", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"2044644", "type"=>"BACKGROUND", "citation"=>"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."}]}, "descriptionModule"=>{"briefSummary"=>"To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).", "detailedDescription"=>"BACKGROUND:\n\nThree 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.\n\nOf the original 834l patients, about 6000 were still alive in March l975. Cause-specific mortality in those patients was assessed through March l980.\n\nDESIGN NARRATIVE:\n\nThe 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.\n\nThe study completion date listed in this record was obtained from the Query/View/Report (QVR) System."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"64 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"No eligibility criteria"}, "identificationModule"=>{"nctId"=>"NCT00000483", "briefTitle"=>"Coronary Drug Project Mortality Surveillance", "organization"=>{"class"=>"NIH", "fullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "orgStudyIdInfo"=>{"id"=>"2"}, "secondaryIdInfos"=>[{"id"=>"R01HL008888-14S1", "type"=>"OTHER_GRANT", "domain"=>"US NIH Grant Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"estrogen", "type"=>"DRUG"}, {"name"=>"clofibrate", "type"=>"DRUG"}, {"name"=>"dextrothyroxine sodium", "type"=>"DRUG"}, {"name"=>"niacin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Roger Sherwin", "affiliation"=>"University of Maryland"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
