Official Title: “Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate- to Severe Hypertensive Patients”

Primary objective:

To evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients

Secondary objective:

To get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: irbesartan/hydrochlorothiazide
  • 50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Number of patients with controlled blood pressure
  • Time Frame: At 3 month
    Safety Issue?: No

Secondary Measures

• Adverse events
  • Time Frame: Throughout the study period
    Safety Issue?: Yes
• Systolic and Diastolic Blood Pressure
  • Time Frame: At month 3 versus baseline
    Safety Issue?: No

Inclusion Criteria:

• Essential hypertensive patients
• Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure
• ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure
• ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
• Patients are willing to discontinue previous antihypertensive medicine

Exclusion Criteria:

• Pregnant or lactating women, or women of child bearing potential without contraceptive method.
• Hypersensitivity to any component of the products or other sulfonamide derived substances.
• Secondary hypertension.
• Severe renal impairment (Creatinine Clearance ≤30ml/min)
• Severe hepatic impairment, biliary cirrhosis and cholestasis.
• Refractory hypokalemia, hypercalcaemia.
• 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: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Mei Mao Study Director Sanofi-Aventis  

Overall Contact: Public Registry GMA  publicregistryGMA@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670566

Study ID Number: IRBEH_L_03170

ClinicalTrials.gov Identifier: NCT00670566

Health Authority: China: State Food and Drug Administration