Hypertension
Conditions
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.
Interventions
50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with controlled blood pressure | At month 3 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Throughout the study period |
| Systolic and Diastolic Blood Pressure | At month 3 versus baseline |
Countries
China
Outcome results
None listed