Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: irbesartan/hydrochlorothiazide (Drug)
Phase: Phase 4
Sponsored by: Sanofi
Official(s) and/or principal investigator(s):
Mei Mao, Study Director, Affiliation: Sanofi
The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of
Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive
The secondary objective is to get systolic blood pressure and diastolic blood pressure goal
attainment rate from CoAprovel in Chinese hypertensive patients.
Official title: Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of patients with controlled blood pressure
Systolic and Diastolic Blood Pressure
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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
- Pregnant or lactating women, or women of child bearing potential without
- Hypersensitivity to any component of the products or other sulfonamide derived
- 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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Shanghai, China
Starting date: April 2008
Last updated: September 14, 2009