Ignite Creation Date:
2024-05-05 @ 9:45 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00957554
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2009-08-11
Brief Title:
IrbesartanAmlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Efficacy and Safety of IrbesartanAmlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
Status:
COMPLETED
Status Verified Date:
2010-10
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:
I-ADD
Brief Summary:
Primary Objective
To demonstrate that the antihypertensive efficacy of the fixed combination irbesartanamlodipine 3005 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure SBP as measured by home blood pressure measurement HBPM after 10 weeks of treatment W10
Secondary Objective
To compare the antihypertensive efficacy of the fixed combination irbesartanamlodipine 3005 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment W10
To compare the antihypertensive efficacy of the fixed combination therapy irbesartanamlodipine 1505 mg with that of irbesartan 150 mg monotherapy after 5 weeks of treatment W5
To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure DBP assessed by HBPM and by office blood pressure measurement OBPM
To determine the incidence and severity of adverse events
To demonstrate that the antihypertensive efficacy of the fixed combination irbesartanamlodipine 3005 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure SBP as measured by home blood pressure measurement HBPM after 10 weeks of treatment W10
Secondary Objective
To compare the antihypertensive efficacy of the fixed combination irbesartanamlodipine 3005 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment W10
To compare the antihypertensive efficacy of the fixed combination therapy irbesartanamlodipine 1505 mg with that of irbesartan 150 mg monotherapy after 5 weeks of treatment W5
To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure DBP assessed by HBPM and by office blood pressure measurement OBPM
To determine the incidence and severity of adverse events
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