Status:
COMPLETED
Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
968 Patients enrolled
Trial Details
Trial ID
NCT00847834
Start Date
December 1 2003
Last Update
September 15 2009
Active Locations (1)
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1
Sanofi aventis administrative office
Beijing, China