Official Title: “A Randomized, Open Label, Cross-Over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Irbesartan/Hydrochlorothiazide
  • Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
• Drug: Irbesartan
  • Administration of irbesartan 150 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 12 weeks on treatment 1 2 week washout period 12 weeks on treatment 2
• Experimental: 2
  • 12 weeks on treatment 2 2 week washout period 12 weeks on treatment 1

Primary Measures

• Forearm vascular resistance
  • Time Frame: At baseline and end of study
    Safety Issue?: No
• Changes of serum TBARS, CRP, IL-6, and VCAM-1
  • Time Frame: Throughout the study period
    Safety Issue?: No
• Office BP measurement of seated SBP and DBP
  • Time Frame: At baseline and after 12-week treatment
    Safety Issue?: No
• Adverse events
  • Time Frame: Throughout the study period
    Safety Issue?: Yes

Secondary Measures

• Office BP measurement of seated SBP and DBP
  • Time Frame: At baseline and after 12-week treatment
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Fern Lim Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00443612

Study ID Number: IRBEH_L_00702

ClinicalTrials.gov Identifier: NCT00443612

Health Authority: Taiwan: Department of Health