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

September 14, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

968

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Sanofi aventis administrative office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Ji Jing, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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