Ignite Creation Date:
2024-05-05 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00564187
Status:
COMPLETED
Last Update Posted:
2007-11-28
First Post:
2007-11-20
Brief Title:
Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel Irbesartan in Hypertensive Outpatients in Current Clinical Practice
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Prospective Multicentric Randomized Open Comparative Phase IV Study Evaluating the Efficacy and Safety of the Dosage Adjustment of Aprovel Irbesartan in Hypertensive Outpatients in Current Clinical Practice
Status:
COMPLETED
Status Verified Date:
2007-11
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
To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment schema N1 maintenance 150 mgday schema n2 300 mgday for 6 more weeks
Secondary
To evaluate the percentage of patients with DBP 90 mmHg at 6 and 12 weeks
To evaluate the percentage of patients with SBP 140 mmHg at 6 and 12 weeks
To evaluate rate of adverse events during the study
To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment schema N1 maintenance 150 mgday schema n2 300 mgday for 6 more weeks
Secondary
To evaluate the percentage of patients with DBP 90 mmHg at 6 and 12 weeks
To evaluate the percentage of patients with SBP 140 mmHg at 6 and 12 weeks
To evaluate rate of adverse events during the study
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