Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-20 @ 1:40 PM
Study NCT ID:
NCT01625494
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 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 irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)
* To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 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 irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)
* To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 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): Irbesartan/amlodipine 150/5 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): Irbesartan/amlodipine 150/5 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1117-9116 | OTHER | UTN | View |