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...
Date First Received: May 15, 2008
Last Updated: May 15, 2008
Verified by: AstraZeneca, May 2008
Clinical Trial Phase: N/A | Start Date: February 2008
Overall Status: Recruiting
Estimated Enrollment: 1000
Brief Summary
Official Title: “Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France”
Condition Keyword(s):
Intervention(s):
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: Cohort, Prospective
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
- Time Frame: At inclusion
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
- Time Frame: 6 and 12 months after
- Percentage of patients stopping its treatment and reasons why
- Time Frame: 12 months after
Safety Issue?: No
- Time Frame: 12 months after
- Percentage of hospitalisations due to heart failure and cardiovascular deaths
- Time Frame: 12 months after
Safety Issue?: No
- Time Frame: 12 months after
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 Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Stephane Bouee, MD, MSc Principal Investigator CEMKA EVAL - Bourg La Reine - France
Overall Contact: AstraZeneca France MC Clinical Study Information + 33 1 41 29 40 25 florence.thomas@astrazeneca.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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
Clinical Trials Authorship and Review
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