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

This study has been completed.
Sponsor:
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00847834
First received: February 18, 2009
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg
Drug: Irbesartan 150mg
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Proportion of patients who reach a diastolic blood pressure <85 mmHg [ Time Frame: At 2, 4 and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 968
Study Start Date: December 2003
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg
Once a day
Drug: Irbesartan 150mg
Once a day
Experimental: 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
 Drug: Irbesartan 150mg / Hydrochlorothiazide 12.5mg
Once a day
Drug: Irbesartan 150mg
Once a day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847834

Locations
China
Sanofi aventis administrative office
Beijing, China
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Ji Jing Sanofi-Aventis
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00847834     History of Changes
Other Study ID Numbers: L_9292
Study First Received: February 18, 2009
Last Updated: September 14, 2009
Health Authority: China: State Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Irbesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 26, 2012