Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)

A study to evaluate the effect of Atacand on patients with heart failure with depressed 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: March 1999

Overall Status: Completed

Estimated Enrollment: 6268

Brief Summary

Official Title: “Candesartan in Heart Fail. Assess. of Reduction in Mortality & Morbidity. Candesartan in Patients With Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function”

Condition Keyword(s):

Intervention(s):

A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 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: 2, 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: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months

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

Clinical Trial Sponsor Information

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Chris Granger, MD Principal Investigator   

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634400

Study ID Number: SH-AHS-0003

ClinicalTrials.gov Identifier: NCT00634400

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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