Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443612
Status:
COMPLETED
Last Update Posted:
2009-10-01
First Post:
2007-03-05
Brief Title:
IrbesartanHydrochlorothiazide National Taiwan University Hospital Listing
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open Label Cross-over Comparative Study of IrbesartanHydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Status:
COMPLETED
Status Verified Date:
2009-09
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
1 To compare the change in forearm vascular resistance following a 12-week regimen of irbesartanhydrochlorothiazide versus irbesartan
2 To assess changes of serum proinflammatory cytokine markers of cardiovascular risks oxidative stress and circulating adhesion molecule including thiobarbiturate acid reactive substances TBARS C-reactive protein CRP interleukin 6 IL-6 and vascular cell adhesion molecule 1 VCAM-1
Secondary
1 To compare the reduction in office blood pressure following a 12-week regimen of irbesartanhydrochlorothiazide versus irbesartan
2 To compare the response rate defined as office Systolic blood pressureSBPdiastolic blood pressure DBP reduce more than 10mmHg from baseline and BP controlled rate defined as SBP140 mmHg and or DBP90 mmHg
3 To ascertain the safety and tolerability of irbesartan hydrochlorothiazide versus irbesartan when administered once daily
4 To determine whether angiotensin II type 1 AT-1 receptor gene polymorphisms including A1166C gene with about 4 of the minor allele frequency in Chinese population and other single nucleotide polymorphisms with a higher frequency of about 10 of minor allele is related to reduction of BP
1 To compare the change in forearm vascular resistance following a 12-week regimen of irbesartanhydrochlorothiazide versus irbesartan
2 To assess changes of serum proinflammatory cytokine markers of cardiovascular risks oxidative stress and circulating adhesion molecule including thiobarbiturate acid reactive substances TBARS C-reactive protein CRP interleukin 6 IL-6 and vascular cell adhesion molecule 1 VCAM-1
Secondary
1 To compare the reduction in office blood pressure following a 12-week regimen of irbesartanhydrochlorothiazide versus irbesartan
2 To compare the response rate defined as office Systolic blood pressureSBPdiastolic blood pressure DBP reduce more than 10mmHg from baseline and BP controlled rate defined as SBP140 mmHg and or DBP90 mmHg
3 To ascertain the safety and tolerability of irbesartan hydrochlorothiazide versus irbesartan when administered once daily
4 To determine whether angiotensin II type 1 AT-1 receptor gene polymorphisms including A1166C gene with about 4 of the minor allele frequency in Chinese population and other single nucleotide polymorphisms with a higher frequency of about 10 of minor allele is related to reduction of BP
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