NCT00670566CompletedPhase 4
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 503
- Locations
- 1
- Primary Endpoint
- Number of patients with controlled blood pressure
Study Overview
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 secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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.
Arms & Interventions
1
Experimental
Intervention: irbesartan/hydrochlorothiazide (Drug)
Outcomes
Primary Outcomes
Number of patients with controlled blood pressure
Time Frame: At month 3
Secondary Outcomes
- Adverse events(Throughout the study period)
- Systolic and Diastolic Blood Pressure(At month 3 versus baseline)
Investigators
Study Sites (1)
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