Systolic Hypertension in the Elderly Program (SHEP)
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|ClinicalTrials.gov Identifier: NCT00000514|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 15, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Cerebrovascular Disorders Heart Diseases Hypertension||Drug: chlorthalidone Drug: atenolol Drug: reserpine||Phase 3|
More than 3 million persons in the United States over the age of 60 have isolated systolic hypertension. They face an excess risk (2-3 fold) of stroke, other cardiovascular disease and death. Population-based data show that the prevalence rises from approximately 8 percent in the age group 60-69 years to approximately 20 percent over the age of 80. Based on available data, an annual stroke rate of 2.0 percent has been estimated in this population. The full-scale clinical trial followed a pilot study conducted from 1980 to 1983. Recruitment in the trial began in March 1985 and was finished in January 1988. Follow-up ended in February 1991. Data analysis continued through October 1996.
A randomized, double-blind trial in which 2,365 subjects were assigned to active treatment and 2,371 to placebo. For the active treatment group, a stepped-care regimen was used which included chlorthalidone 12.5 or 25 mg/day, and as needed, addition of atenolol 25 or 50 mg/day or reserpine, 0.05 or 0.10 mg/day. Treatment goal was to reduce systolic blood pressure by at least 20 mm Hg from baseline and to below 160 mm Hg with minimal amounts of study medication. The primary endpoint was the incidence of fatal and non-fatal stroke. Secondary endpoints were cardiovascular and coronary morbidity and mortality, all-cause mortality, and quality-of-life measures.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||June 1984|
|Study Completion Date :||October 1996|
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|Ages Eligible for Study:||60 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000514
|OverallOfficial:||C. Hawkins||University of Texas|
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
|Other Study ID Numbers:||
|First Posted:||October 28, 1999 Key Record Dates|
|Last Update Posted:||April 15, 2016|
|Last Verified:||January 2005|
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