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Trial NCT00000509

Resource URI: http://static.linkedct.org/resource/trials/NCT00000509
linkedct:brief_title Potassium and Sodium to Control Blood Pressure in Hypertensives
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, ages 45 to 68. Subjects were hypertensive, were treated for at least 3.5 years with antihypertensive drugs and whose diastolic blood pressure was less than 90 mm Hg.
linkedct:description BACKGROUND: Appropriately increased interest and concern about high blood pressure as a major public health problem coincided with the indication that the risks of hypertension-related morbidity and mortality could be reduced by reduction of blood pressure. Consensus suggestions that individualized approaches be used in treating patients with mild hypertension stimulated further investigations of non-pharmacological methods. Such investigations were also of considerable interest in relation to understanding the physiology of blood pressure control as well as the development of less costly non-drug therapies. Interest was heightened by information suggesting that there might be distinctly harmful side effects related to antihypertensive drug therapy, particularly thiazide diuretics, in some settings. Studies of non-drug therapies included dietary modifications primarily involving weight reduction and sodium restriction with increasing recent concern about other factors such as alcohol intake, dietary fat, calcium, magnesium, and potassium intake. DESIGN NARRATIVE: Randomized, double-blind. One hundred forty-five subjects were randomized into a low sodium placebo group in which sodium intake was restricted to no more than 80 mEq/day, 142 subjects into a potassium supplementation (96 mEq/day) group whose sodium intake was also restricted to no more than 80 mEq/day. After 12 weeks of intervention, antihypertensive drugs were withdrawn. Follow-up of each participant was for at least two years. The primary endpoint was the proportion of subjects requiring antihypertensive medication at various points following randomization.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Male
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 68 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000509
rdfs:label Trial NCT00000509
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000509
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 28
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000509>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/39050>
linkedct:reference <http://static.linkedct.org/resource/reference/40593>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1983
linkedct:study_design Treatment, Randomized, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.
rdf:type linkedct:trials
linkedct:verification_date January 2000