Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00956644
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2009-08-10
Brief Title:
IrbesartanAmlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Efficacy and Safety of IrbesartanAmlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 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-COMBINE
Brief Summary:
Primary Objective
To demonstrate that the antihypertensive efficacy of the fixed combination irbesartanamlodipine 1505 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure SBP as measured by home blood pressure measurement HBPM after 5 weeks of treatment W5
Secondary Objective
To compare the antihypertensive efficacy of the fixed combination irbesartanamlodipine 1505 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment W5
To compare the antihypertensive efficacy of the fixed combination therapy irbesartanamlodipine 15010 mg with that of amlodipine 10 mg monotherapy at the end of treatment W10
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 1505 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure SBP as measured by home blood pressure measurement HBPM after 5 weeks of treatment W5
Secondary Objective
To compare the antihypertensive efficacy of the fixed combination irbesartanamlodipine 1505 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment W5
To compare the antihypertensive efficacy of the fixed combination therapy irbesartanamlodipine 15010 mg with that of amlodipine 10 mg monotherapy at the end of treatment W10
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