Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263003
Status:
COMPLETED
Last Update Posted:
2007-12-07
First Post:
2005-12-06
Brief Title:
IrbesartanHydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open Label Comparative Study of IrbesartanHydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Study Objectives
To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan hydrochlorothiazide using irbesartan as a reference
To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan hydrochlorothiazide using irbesartan as a reference
To compare the response rate defined as office Systolic Blood PressureDiastolic Blood Pressure reduce more than 10mmHg from Week 0 of patients after 4-week and 8-week regimen of irbesartan hydrochlorothiazide versus irbesartan
To compare the proportion of patients requiring titration after 4-week regimen of irbesartanhydrochlorothiazide versus irbesartan
To ascertain the safety and tolerability of irbesartan hydrochlorothiazide versus irbesartan when administered once daily
To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan hydrochlorothiazide using irbesartan as a reference
To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan hydrochlorothiazide using irbesartan as a reference
To compare the response rate defined as office Systolic Blood PressureDiastolic Blood Pressure reduce more than 10mmHg from Week 0 of patients after 4-week and 8-week regimen of irbesartan hydrochlorothiazide versus irbesartan
To compare the proportion of patients requiring titration after 4-week regimen of irbesartanhydrochlorothiazide versus irbesartan
To ascertain the safety and tolerability of irbesartan hydrochlorothiazide versus irbesartan when administered once daily
Detailed Description:
None
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