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

The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.

The secondary objective is 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: March 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 month 3
    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  

Information obtained from ClinicalTrials.gov on July 02, 2009

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