A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular...
Date First Received: March 7, 2008
Last Updated: March 12, 2008
Verified by: AstraZeneca, March 2008
Clinical Trial Phase: Phase 3 | Start Date: June 1999
Overall Status: Completed
Estimated Enrollment: 734
Brief Summary
Official Title: “Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Preserved Left Ventricular Systolic Function”
Condition Keyword(s):
Intervention(s):
A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular function
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Study Primary Completion Date: May 2003
Intervention(s) in this Clinical Trial
- Drug: Candesartan
- Drug: Placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Cardiovascular mortality or hospitalisation due to congestive heart failure
- Time Frame: , 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
- Time Frame: , 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
Secondary Measures
- Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
- Time Frame: Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
- Time Frame: Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male or female aged 18 or above
- Congestive Heart Failure with symptoms for more than 4 weeks before starting study
- Provision of informed consent
Exclusion Criteria:
- Current low blood pressure with symptoms
- Liver disease considered significant by the study doctor
- Pregnant or lactating females
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
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
Dr Salim Yusuf Principal Investigator
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634712
Study ID Number: SH-AHS-0007
ClinicalTrials.gov Identifier: NCT00634712
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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