Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population
NCT ID: NCT00847834
Last Updated: 2009-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
968 participants
INTERVENTIONAL
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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1
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
Irbesartan 150mg / Hydrochlorothiazide 12.5mg
Once a day
Irbesartan 150mg
Once a day
2
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
Irbesartan 150mg / Hydrochlorothiazide 12.5mg
Once a day
Irbesartan 150mg
Once a day
Interventions
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Irbesartan 150mg / Hydrochlorothiazide 12.5mg
Once a day
Irbesartan 150mg
Once a day
Eligibility Criteria
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Inclusion Criteria
* 90 mmHg ≤ Diastolic blood pressure \< 110 mmHg
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Ji Jing
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi aventis administrative office
Beijing, , China
Countries
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Other Identifiers
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L_9292
Identifier Type: -
Identifier Source: org_study_id
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