Status:
COMPLETED
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 second...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT00670566
Start Date
April 1 2008
Last Update
September 15 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Shanghai, China