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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

Status: Completed

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

Clinical Details

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

Secondary outcome:

Adverse events

Systolic and Diastolic Blood Pressure


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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
Additional Information

Starting date: April 2008
Last updated: September 14, 2009

Page last updated: August 20, 2015

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