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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Hydrochlorothiazide; Irbesartan

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.