DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Irbesartan 150mg / Hydrochlorothiazide 12.5mg (Drug); Irbesartan 150mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Ji Jing, Study Director, Affiliation: Sanofi


To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.

Clinical Details

Official title: Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients who reach a diastolic blood pressure <85 mmHg


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion criteria:

- Systolic blood pressure < 180 mmHg

- 90 mmHg ≤ Diastolic blood pressure < 110 mmHg

Exclusion criteria:

- Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should

be using a reliable contraceptive method

- Known or suspected secondary hypertension (e. g., coarctation of aorta, renovascular

stenosis, etc.)

- Presence of clinically significant ventricular or supraventricular arrhythmias, or

second or third degree atrioventricular block, or sick sinus syndrome

- ALAT[SGPT]>2 times of upper limit,

- ASAT[SGOT]>2 times of upper limit

- Patients with known renal disease

- Serum potassium > normal upper limit

- Uncontroled BD(FBG>10mmol/L or PBG>12. 22mmol/L)

- Patients treated with tricyclic antidepressants

- Clinical hematological disease.

- Patients with a history of irbesartan, or hydrochlorothiazide sensitivity defined as

irbesartan, or hydrochlorothiazide discontinuation due to medically significant adverse effects. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Sanofi aventis administrative office, Beijing, China
Additional Information

Starting date: December 2003
Last updated: September 14, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017