Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: irbesartan/hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Mei Mao, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
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.
Clinical Details
Official title: Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Number of patients with controlled blood pressure
Secondary outcome: Adverse eventsSystolic and Diastolic Blood Pressure
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
Sanofi-Aventis Administrative Office, Shanghai, China; Recruiting
Additional Information
Starting date: April 2008
Last updated: October 2, 2008
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