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

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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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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