Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Hydrochlorothiazide; Irbesartan

Criteria

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.