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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: irbesartan/hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670566

IRBEH_L_03170

Details and patient eligibility

About

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.

Enrollment: 503 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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503 participants in 1 patient group

1

Experimental group

Treatment:

Drug: irbesartan/hydrochlorothiazide