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Trial NCT00000594

Resource URI: http://static.linkedct.org/resource/trials/NCT00000594
PropertyValue
linkedct:brief_title NHLBI Type II Coronary Intervention Study
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6176>
linkedct:condition <http://static.linkedct.org/resource/condition/8483>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women with angiographically demonstrated coronary artery disease.
linkedct:description BACKGROUND: There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. It should be noted that patients in the CPPT did not have known preexisting coronary heart disease. DESIGN NARRATIVE: A randomized, double-blind trial, with single experimental and control groups. The experimental group received drug therapy (cholestyramine); the control group received placebo. Both groups received diet therapy. The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. Patients were followed under therapy for at least 5 years.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 55 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000594
rdfs:label Trial NCT00000594
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000594
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 400
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28619>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000594>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/31533>
linkedct:reference <http://static.linkedct.org/resource/reference/37022>
linkedct:reference <http://static.linkedct.org/resource/reference/40067>
linkedct:reference <http://static.linkedct.org/resource/reference/42902>
linkedct:reference <http://static.linkedct.org/resource/reference/43316>
linkedct:reference <http://static.linkedct.org/resource/reference/43317>
linkedct:reference <http://static.linkedct.org/resource/reference/43864>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date November 1971
linkedct:study_design Prevention, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct:summary To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.
rdf:type linkedct:trials
linkedct:verification_date January 2000