drugset / Trial / NCT00443612

Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

NCT00443612

Phase 4 Completed 60 enrolled Sanofi
RandomizedCrossoverOpen-labelTreatment

Summary

Primary: 1. To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide 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 irbesartan/hydrochlorothiazide versus irbesartan 2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP\<140 mmHg and /or DBP\<90 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

Timeline

Start
2006-09
Primary completion
2008-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown 12.5 mg
Subject Irbesartan Small molecule 150 mg

Indications