Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: irbesartan/hydrochlorothiazide

• Registration Number: NCT00670566
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Primary Completion: 2009-03
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	irbesartan/hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Number of patients with controlled blood pressure	At month 3

Secondary Outcome Measures

Name	Time	Method
Adverse events	Throughout the study period
Systolic and Diastolic Blood Pressure	At month 3 versus baseline

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Shanghai, China