Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01625494
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2012-06-19
Brief Title:
Study of Efficacy and Safety of IrbesartanAmlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Prospective Open-label Multicentre Study of Efficacy and Safety of IrbesartanAmlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Primary Objective
- To assess the proportion of patients with controlled Office Blood Pressure Measurements OBPM defined as Systolic blood pressure 140 mmHg and Diastolic blood pressure 90mmHg at the end of the study
Secondary Objectives
To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartanamlodipine on OBPM SBP systolic blood pressure and DBP diastolic blood pressure
To examine the proportion of patients with controlled OBPM systolic BP140 mm Hg and diastolic BP90 mmHg of the different dose groups over time
To determine the incidence and severity of adverse events
- To assess the proportion of patients with controlled Office Blood Pressure Measurements OBPM defined as Systolic blood pressure 140 mmHg and Diastolic blood pressure 90mmHg at the end of the study
Secondary Objectives
To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartanamlodipine on OBPM SBP systolic blood pressure and DBP diastolic blood pressure
To examine the proportion of patients with controlled OBPM systolic BP140 mm Hg and diastolic BP90 mmHg of the different dose groups over time
To determine the incidence and severity of adverse events
Detailed Description:
16 weeks
V1 week 0 Inclusion visit
V2 Week 4 Irbesartanamlodipine 1505 mg fixed combination visit
V3 Week 8 1st dose escalation for patients in whom OBPM is not controlled SBP 140 mmHg or DBP 90mmHg
V4 Week 12 2nd Dose escalation visit for patients in whom OBPM is not controlled SBP 140 mmHg or DBP 90mmHg
V5 Week 16 End of study visit
V1 week 0 Inclusion visit
V2 Week 4 Irbesartanamlodipine 1505 mg fixed combination visit
V3 Week 8 1st dose escalation for patients in whom OBPM is not controlled SBP 140 mmHg or DBP 90mmHg
V4 Week 12 2nd Dose escalation visit for patients in whom OBPM is not controlled SBP 140 mmHg or DBP 90mmHg
V5 Week 16 End of study visit
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1117-9116 | OTHER | UTN | None |