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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847834
First Posted: February 19, 2009
Last Update Posted: September 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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: Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of patients who reach a diastolic blood pressure <85 mmHg [ Time Frame: At 2, 4 and 8 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847834


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00847834     History of Changes
Other Study ID Numbers: L_9292
First Submitted: February 18, 2009
First Posted: February 19, 2009
Last Update Posted: September 15, 2009
Last Verified: September 2009

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