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Trial NCT00000513

Resource URI: http://static.linkedct.org/resource/trials/NCT00000513
PropertyValue
linkedct:brief_title Trial of Antihypertensive Intervention Management
linkedct:condition <http://static.linkedct.org/resource/condition/13668>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:criteria Men and women, ages 21 to 65, with mild hypertension in the range of 90 to 100 mm Hg diastolic blood pressure. Subjects were obese (110-150 percent of ideal weight).
linkedct:description BACKGROUND: The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported Dietary Intervention Study of Hypertension (DISH) which concluded in March 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs. TAIM was initiated in April 1984 and continued for four years at three centers and added to DISH the art of evaluating combined drug and dietary treatments. COTAIM was continued at three clinical sites in July 1988. Analysis of COTAIM results continued through November 1994 under grant R01HL40072. DESIGN NARRATIVE: TAIM patients were randomly assigned to one of three diets and to one of three drug regimens. The dietary interventions consisted of a weight loss program, sodium reduction with increased potassium intake, or no change in diet. The drug regimen consisted of a beta-blocker (atenolol), a thiazide-like diuretic (chlorthalidone), or placebo. The major endpoint was change in diastolic blood pressure after six months of intervention. Individuals who did not reach goal blood pressure after six months received additional drugs. Other endpoints included total risk factor score change, psychological function, and lifestyle change. COTAIM consisted of two studies with a total of 600 subjects. COTAIM I compared the TAIM weight loss group to a randomly selected half of the usual diet group. The primary endpoint of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM baseline and the end of COTAIM, a five year period. COTAIM II added a weight loss regimen both to the sodium restriction/potassium supplementation groups and to the other half of the usual diet group. The primary outcome was control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of COTAIM, a two-year period.
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 65 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000513
rdfs:label Trial NCT00000513
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000513
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 32
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/1052>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/32803>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/42510>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/57203>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000513>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/23837>
linkedct:reference <http://static.linkedct.org/resource/reference/24642>
linkedct:reference <http://static.linkedct.org/resource/reference/30986>
linkedct:reference <http://static.linkedct.org/resource/reference/33270>
linkedct:reference <http://static.linkedct.org/resource/reference/33588>
linkedct:reference <http://static.linkedct.org/resource/reference/37681>
linkedct:reference <http://static.linkedct.org/resource/reference/37784>
linkedct:reference <http://static.linkedct.org/resource/reference/37879>
linkedct:reference <http://static.linkedct.org/resource/reference/39213>
linkedct:reference <http://static.linkedct.org/resource/reference/39487>
linkedct:reference <http://static.linkedct.org/resource/reference/46318>
linkedct:reference <http://static.linkedct.org/resource/reference/46732>
linkedct:reference <http://static.linkedct.org/resource/reference/48395>
linkedct:reference <http://static.linkedct.org/resource/reference/48926>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date April 1984
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to determine the efficacy of dietary management and/or drug therapy, namely thiazide-like diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the effects of long-term weight reduction, and sodium/potassium changes added to weight reduction, as well as the original drug treatment, on the failure rate of blood pressure control.
rdf:type linkedct:trials
linkedct:verification_date January 2000