Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 8:26 PM
Study NCT ID:
NCT00500604
Status:
COMPLETED
Last Update Posted:
2010-07-19
First Post:
2007-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 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 irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg 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 doctor's 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 doctor's 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 doctor's 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 doctor's office at weeks 16 and 24
* To determine the incidence and severity of adverse events
Detailed Description:
None
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?: