Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421863
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2007-01-12
Brief Title:
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Sponsor:
Heart Care Foundation
Organization:
Heart Care Foundation
Study Overview
Official Title:
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Multicenter prospective randomised open study comparing the effect of the following two strategies in hypertensive subjects 55 years and poorly controlled systolic blood pressure 150 mmHg by antihypertensive treatment
usual strategy reduction of systolic blood pressure to below 140 mmHg independently of diastolic blood pressure levels
intensive strategy reduction of systolic blood pressure to below 130 mmHg independently of diastolic blood pressure levels
During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled systolic blood pressure 150 mmHgby current drug treatment At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out clinical visit routine laboratory tests 12-lead ECG At this point eligible patients will be randomised to one of the two blood pressure goals outlined above
Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study 4 8 12 16 20 24 months
usual strategy reduction of systolic blood pressure to below 140 mmHg independently of diastolic blood pressure levels
intensive strategy reduction of systolic blood pressure to below 130 mmHg independently of diastolic blood pressure levels
During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled systolic blood pressure 150 mmHgby current drug treatment At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out clinical visit routine laboratory tests 12-lead ECG At this point eligible patients will be randomised to one of the two blood pressure goals outlined above
Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study 4 8 12 16 20 24 months
Detailed Description:
Study partially sponsored by Boehringer Ingelheim Sanofi-Aventis Pfizer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None