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

This study has been completed.

First Received: April 30, 2008 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00670566

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: irbesartan/hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Irbesartan

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Number of patients with controlled blood pressure [ Time Frame: At month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
Systolic and Diastolic Blood Pressure [ Time Frame: At month 3 versus baseline ] [ Designated as safety issue: No ]

Enrollment:	503
Study Start Date:	April 2008
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: irbesartan/hydrochlorothiazide 50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670566

Locations

China
Sanofi-aventis Administrative Office
Shanghai, China

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Mei Mao

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	IRBEH_L_03170
Study First Received:	April 30, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00670566 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Sodium Chloride Symporter Inhibitors
Diuretics
Irbesartan
Vascular Diseases

Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Irbesartan
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 03, 2009