Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

Verified by: AstraZeneca, July 2010
First Received: May 15, 2008 | Last Updated: December 1, 2010 | Phase: N/A | Start Date: January 2008
Overall Status: Completed | Estimated Enrollment: 450
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The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical...

Brief Summary

Official Title: “Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France”

The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

  • Drug: Candesartan
    • Oral tablets

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • Outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Outcome Measures for this Clinical Trial

Primary Measures

  • Profile of patients treated with candesartan for heart failure
    • Time Frame: At inclusion
      Safety Issue?: No

Secondary Measures

  • Percentage of patients taking correctly its treatment : indication, contraindication, drug titration, treatment monitoring
    • Time Frame: 6 and 12 months after
      Safety Issue?: No
  • Percentage of patients stopping its treatment and reasons why
    • Time Frame: 12 months after
      Safety Issue?: No
  • Percentage of hospitalisations due to heart failure and cardiovascular deaths
    • Time Frame: 12 months after
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Exclusion Criteria:

  • patients included in a clinical trial the last 30 days before consultation
  • patients unable to answer the questions for linguistic or cognitive reasons
  • patients who will be difficult to follow during the one year study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Stephane Bouee, MD, MSc Principal Investigator CEMKA EVAL - Bourg La Reine - France  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679640

Study ID Number: NIS-CFR-ATA-2007/1

ClinicalTrials.gov Identifier: NCT00679640

Health Authority: France: Haute Autorité de Santé Transparency Commission

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00679640