Hypertension
Conditions
Brief 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
Interventions
Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
DRUGIrbesartan
Administration of irbesartan 150 mg/day
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients with mild to moderate hypertension with office diastolic BP (DBP) 90-109 mmHg and/or systolic BP (SBP) 140-179 mmHg before entering each treatment
Exclusion criteria
* females: who are pregnant or breast feeding * office DBP ≧ 110 mmHg or office SBP ≧ 180 mmHg * history of significant cardiovascular diseases which include: acute myocardial infarction within six months or any ischemic heart disease requiring medication, or cerebrovascular disease * history of significant renal diseases including: serum creatinine \> 3.0 mg/dl, or creatinine clearance \< 30 ml/min. * severe biliary cirrhosis and cholestasis * refractory hypokalemia, hypercalcemia * history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication * hepatic disease as indicated by any of the following : Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvate Transaminase (SGPT) \>3 x upper limit of normal, or serum bilirubin \> 2 x upper limit of normal The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forearm vascular resistance | At baseline and end of study |
| Changes of serum TBARS, CRP, IL-6, and VCAM-1 | Throughout the study period |
| Office BP measurement of seated SBP and DBP | At baseline and after 12-week treatment |
| Adverse events | Throughout the study period |
Secondary
| Measure | Time frame |
|---|---|
| Office BP measurement of seated SBP and DBP | At baseline and after 12-week treatment |
Countries
Taiwan
Outcome results
None listed