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

Study Objectives : - To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference. - To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference. - To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan. - To compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan - To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Irbesartan/hydrochlorothiazide
• Drug: Irbesartan

Primary Measures

• Compare the reduction in office BP following a 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan

Secondary Measures

• Compare the reduction in office BP following a 4-week regimen of irbesartan / hydrochlorothiazide versus irbesartan
• Compare the response rate (defined as office SBP/DBP reduce more than 10mmHg from week 0) of patients after 4-week and 8-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
• Compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
• Ascertain the safety and tolerability of irbesartan/hydrochlorothiazide versus irbesartan when administered once daily.

Inclusion Criteria:

• Patients with mild to moderate hypertension with office Diastolic Blood Pressure (DBP) 90-109 mmHg and/or Systolic Blood Pressure (SBP) 140-179 mmHg
• All women of child-bearing potential must have negative urine pregnancy tests within a week prior to initiation of therapy

Exclusion Criteria:

• females who are pregnant or breast feeding
• office DBP ≥ 110 mmHg or office SBP ≥ 180 mmHg
• history of significant cardiovascular diseases which includes:
• acute myocardial infarction within six months or any ischemic heart disease requiring medication.
• cerebrovascular disease
• history of significant renal diseases including:
• serum creatinine > 3.0 mg/dl.
• 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:
• SGOT or SGPT >3 x upper limit of normal.
• Serum bilirubin > 2 x upper limit of normal.
• any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objectives.
• any other investigational drug given within 30 days of initiation of therapy, and participation in other clinical studies while enrolled in this protocol.
• 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

Sharon CHANG, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00263003

Study ID Number: PM_L_0094

ClinicalTrials.gov Identifier: NCT00263003

Health Authority: Taiwan: Department of Health