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

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

Official Title
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Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg
* Drug: Irbesartan 150mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg<br>* Once a day<br>Drug: Irbesartan 150mg<br>* Once a day<br>|
| Experimental: 2<br>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 | Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg<br>* Once a day<br>Drug: Irbesartan 150mg<br>* Once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who reach a diastolic blood pressure <85 mmHg |  | At 2, 4 and 8 weeks |