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Trial NCT00000522

Resource URI: http://static.linkedct.org/resource/trials/NCT00000522
PropertyValue
linkedct:brief_title Treatment of Mild Hypertension Study (TOMHS)
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 45 to 69, with mild hypertension (diastolic blood pressure of 90-99 mm Hg at two of three visits for untreated individuals. Patients who received drug therapy must have had a DBP less than 95 mm Hg two to four weeks after drug.
linkedct:description BACKGROUND: Dietary sodium reduction has a mild effect on the reduction of hypertension. Weight loss, while achievable in the short-run with diet alone, may also have only mild effects on hypertension and is very difficult to maintain with diet and/or behavior modification. Alteration of patients' lifestyles to decrease excessive alcohol intake is somewhat controversial. Medications, on the other hand, have clear benefits in terms of blood pressure lowering, and in the case of diuretics and beta-blockers, reduction in cardiovascular morbidity and mortality. However, there is concern about their justified use in mild hypertension since each one has side effects, some of which may have long-term implications, such as alteration in serum lipids. Newer classes of drugs--calcium antagonists, angiotensin converting enzyme inhibitors, alpha blockers--had not previously been compared long-term with diuretics and beta-blockers. DESIGN NARRATIVE: TOMHS I enrolled 902 men and women to determine the feasibility of a larger trial. Participants were randomized in a double-blind manner to one of six treatment groups and within two strata. Stratum I was for participants not on antihypertensive drugs and Stratum II for those on antihypertensive drugs at initial screening. There were six treatment arms: placebo, a diuretic (chlorthalidone), a beta-adrenergic blocking agent (acebutolol), an alpha blocker (doxazosin mesylate), a calcium antagonist (amlodipine maleate), and an angiotensin converting enzyme inhibitor (enalapril maleate). All participants received a lifestyle intervention program that included reduction of sodium chloride and alcohol intake as well as weight reduction and increase in physical activity. All participants were followed for at least 48 months, with an average of 54 months. The primary endpoint was lowering of blood pressure. The treatments were also compared for effects on blood chemistries including lipoproteins, echocardiographic left ventricular mass, ventricular ectopic activity and ST-T changes of ischemia as measured by ambulatory ECG monitoring, side effects, and quality of life. Randomization took place between October 1986 and March 1988. Active follow-up ended in March-April 1992. Data analysis ended in May 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 69 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:end_date May 1994
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000522
rdfs:label Trial NCT00000522
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000522
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 41
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/49723>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000522>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/2803>
linkedct:reference <http://static.linkedct.org/resource/reference/38111>
linkedct:reference <http://static.linkedct.org/resource/reference/38515>
linkedct:reference <http://static.linkedct.org/resource/reference/38516>
linkedct:reference <http://static.linkedct.org/resource/reference/3921>
linkedct:reference <http://static.linkedct.org/resource/reference/40709>
linkedct:reference <http://static.linkedct.org/resource/reference/44781>
linkedct:reference <http://static.linkedct.org/resource/reference/46112>
linkedct:reference <http://static.linkedct.org/resource/reference/46322>
linkedct:reference <http://static.linkedct.org/resource/reference/47074>
linkedct:reference <http://static.linkedct.org/resource/reference/47613>
linkedct:reference <http://static.linkedct.org/resource/reference/48402>
linkedct:reference <http://static.linkedct.org/resource/reference/48403>
linkedct:reference <http://static.linkedct.org/resource/reference/48787>
linkedct:reference <http://static.linkedct.org/resource/reference/48986>
linkedct:reference <http://static.linkedct.org/resource/reference/49648>
linkedct:reference <http://static.linkedct.org/resource/reference/49761>
linkedct:reference <http://static.linkedct.org/resource/reference/51652>
linkedct:reference <http://static.linkedct.org/resource/reference/51847>
linkedct:reference <http://static.linkedct.org/resource/reference/53091>
linkedct:reference <http://static.linkedct.org/resource/reference/9073>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 1985
linkedct:study_design Treatment, Randomized, Placebo Control
linkedct:study_type Interventional
linkedct:summary To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
rdf:type linkedct:trials
linkedct:verification_date March 2001