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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 February 12, 2009
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 events

Systolic 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

Page last updated: February 12, 2009

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