Hypertension
Conditions
Brief summary
To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.
Interventions
DRUGIrbesartan 150mg / Hydrochlorothiazide 12.5mg
Once a day
DRUGIrbesartan 150mg
Once a day
Sponsors
Sanofi
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who reach a diastolic blood pressure <85 mmHg | At 2, 4 and 8 weeks |
Countries
China
Outcome results
None listed