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Completed

NCT Number: NCT00847834

Irbesartan-Hydrochlorothiazide Phase IV Study: 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi aventis administrative office

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan 150mg / Hydrochlorothiazide 12.5mg

Drug

Once a day

Irbesartan 150mg

Drug

Once a day

Primary outcomes

  1. Proportion of patients who reach a diastolic blood pressure <85 mmHg

    Time frame: At 2, 4 and 8 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
First posted
Feb 19, 2009
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.