Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000514
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
1999-10-27
Brief Title:
Systolic Hypertension in the Elderly Program SHEP
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke The secondary objectives were to evaluate the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension possible adverse effects of chronic use of antihypertensive drug treatment in this population the effect of therapy on indices of quality-of-life the natural history of isolated systolic hypertension in the placebo population
Detailed Description:
BACKGROUND
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 20 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
DESIGN NARRATIVE
A randomized double-blind trial in which 2365 subjects were assigned to active treatment and 2371 to placebo For the active treatment group a stepped-care regimen was used which included chlorthalidone 125 or 25 mgday and as needed addition of atenolol 25 or 50 mgday or reserpine 005 or 010 mgday 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
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 20 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
DESIGN NARRATIVE
A randomized double-blind trial in which 2365 subjects were assigned to active treatment and 2371 to placebo For the active treatment group a stepped-care regimen was used which included chlorthalidone 125 or 25 mgday and as needed addition of atenolol 25 or 50 mgday or reserpine 005 or 010 mgday 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: