Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500604
Status:
COMPLETED
Last Update Posted:
2010-07-19
First Post:
2007-07-11
Brief Title:
Efficacy of IrbesartanHydrochlorothiazide Versus ValsartanHydrochlorothiazide in Mild to Moderate Hypertension
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Comparative Study of the Efficacy of IrbesartanHydrochlorothiazide 30025 mg Versus ValsartanHydrochlorothiazide 16025 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension
Status:
COMPLETED
Status Verified Date:
2010-07
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:
COSIMA2
Brief Summary:
The primary objective is to compare the efficacy of irbesartanhydrochlorothiazide 30025mg against valsartanhydrochlorothiazide 16025mg in reducing mean systolic blood pressure SBP as measured by home blood pressure monitoring HBPM after 24 weeks compared with baseline
The secondary objectives are
To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctors office at weeks 16 and 24
To compare the differences in mean Diastolic Blood Pressure DBP mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
To compare the difference in mean SBP evaluated by HBPM at week 16
To compare the differences in mean SBP and DBP evaluated at the doctors office at weeks 16 and 24
To determine the incidence and severity of adverse events
The secondary objectives are
To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctors office at weeks 16 and 24
To compare the differences in mean Diastolic Blood Pressure DBP mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
To compare the difference in mean SBP evaluated by HBPM at week 16
To compare the differences in mean SBP and DBP evaluated at the doctors office at weeks 16 and 24
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