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