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

Tracking Information

First Received Date ^ICMJE

April 30, 2008

Last Updated Date

September 14, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00670566 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: irbesartan/hydrochlorothiazide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

503

Completion Date

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00670566

Responsible Party

Medical Affairs Study Director, Sanofi-aventis

Study ID Numbers ^ICMJE

IRBEH_L_03170

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mei Mao

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP