Skip to main content
OpenTrials
Completed

NCT Number: NCT00670566

Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients

The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.

The secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Essential hypertensive patients
  • Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
  • Patients are willing to discontinue previous antihypertensive medicine

Exclusion criteria

  • Pregnant or lactating women, or women of child bearing potential without contraceptive method.
  • Hypersensitivity to any component of the products or other sulfonamide derived substances.
  • Secondary hypertension.
  • Severe renal impairment (Creatinine Clearance ≤30ml/min)
  • Severe hepatic impairment, biliary cirrhosis and cholestasis.
  • Refractory hypokalemia, hypercalcaemia.

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/hydrochlorothiazide

Drug

50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks

Other names: CoAprovel

Primary outcomes

  1. Number of patients with controlled blood pressure

    Time frame: At month 3

Secondary outcomes

  1. Adverse events

    Time frame: Throughout the study period

  2. Systolic and Diastolic Blood Pressure

    Time frame: At month 3 versus baseline

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
May 2, 2008
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.

Related clinical trials

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