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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg; Drug: Irbesartan 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847834

L_9292

Details and patient eligibility

About

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

Enrollment: 968 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

968 participants in 2 patient groups

1

Experimental group

Description:

4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by: If DBP<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg

Treatment:

Drug: Irbesartan 150mg

Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg

2

Experimental group

Description:

2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by: If DBP<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg

Treatment:

Drug: Irbesartan 150mg

Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg