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Trial NCT00000474

Resource URI: http://static.linkedct.org/resource/trials/NCT00000474
linkedct:brief_title Prevention and Treatment of Hypertension Study (PATHS)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5477>
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 with a diastolic blood pressure of 80 to 89 mm Hg and alcohol intake of 21 drinks or more per week.
linkedct:description BACKGROUND: Numerous observational epidemiologic studies have established ethanol intake as one of the most important determinants of blood pressure levels. However, data from intervention studies were very limited. The study was an inter-agency agreement involving the Veterans Administration and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Protocol development occurred between October 1988 and June 1989. The protocol was approved by the VA Cooperative Studies Evaluation Committee in July 1989 and reviewed by a separate Data and Safety Monitoring Board in September 1989. DESIGN NARRATIVE: Subjects were randomized to intervention or control groups. Intervention aimed to reduce alcohol intake to no more than 14 drinks per week and 50 percent or less of each participant's baseline level. The intervention technique consisted of a cognitive-behavioral program, the intensive phase of which consisted of six counseling sessions over three months. Echocardiograms were obtained at baseline and six months after randomization. Biochemical markers were used to validate changes in alcohol consumption. The trial included an eighteen-month feasibility phase with six-month follow-up and a 36-month main trial with two years of follow-up. Recruitment for the full-scale trial ended in June 1993. Final study visits were conducted in September and October 1994.
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 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 1994
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000474
rdfs:label Trial NCT00000474
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000474
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 63
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000474>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/46254>
linkedct:reference <http://static.linkedct.org/resource/reference/54519>
linkedct:reference <http://static.linkedct.org/resource/reference/55895>
linkedct:reference <http://static.linkedct.org/resource/reference/855>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1989
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct:summary To evaluate the long-term effect of reduction of alcohol intake on blood pressure in moderate but non-dependent drinkers with mild hypertension or high normal blood pressure.
rdf:type linkedct:trials
linkedct:verification_date June 2001