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Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
This study has been completed.

First Received on March 7, 2008.   Last Updated on January 24, 2011   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00634400
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
 Drug: Candesartan
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression Heart Failure
Drug Information available for: CV 11974 Candesartan cilexetil
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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 Outcome 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 ]

Estimated Enrollment: 6268
Study Start Date: March 1999
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Candesartan
Other Name: Atacand
Placebo Comparator: 2 Drug: Placebo
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634400

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Chris Granger, MD
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Ariti CA, Cleland JG, Pocock SJ, Pfeffer MA, Swedberg K, Granger CB, McMurray JJ, Michelson EL, Ostergren J, Yusuf S. Days alive and out of hospital and the patient journey in patients with heart failure: Insights from the candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) program. Am Heart J. 2011 Nov;162(5):900-6. Epub 2011 Oct 7.
Preiss D, Zetterstrand S, McMurray JJ, Ostergren J, Michelson EL, Granger CB, Yusuf S, Swedberg K, Pfeffer MA, Gerstein HC, Sattar N; Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Investigators. Predictors of development of diabetes in patients with chronic heart failure in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) program. Diabetes Care. 2009 May;32(5):915-20. Epub 2009 Feb 5.

ClinicalTrials.gov Identifier: NCT00634400     History of Changes
Other Study ID Numbers: SH-AHS-0003, D2454C00003
Study First Received: March 7, 2008
Last Updated: January 24, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Federal Agency for Medicinal Products and Health Products;   Canada: Health Canada;   Czech Republic: State Institute for Drug Control;   Denmark: Danish Medicines Agency;   Finland: Finnish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Hungary: National Institute of Pharmacy;   Iceland: Icelandic Medicines Control Agency;   Ireland: Ministry of Health;   Italy: Ministry of Health;   Malaysia: Ministry of Health;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Norway: Norwegian Medicines Agency;   Poland: Ministry of Health;   Portugal: National Pharmacy and Medicines Institute;   Russia: Pharmacological Committee, Ministry of Health;   Singapore: Health Sciences Authority;   South Africa: Department of Health;   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency;   Switzerland: Swissmedic;   United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Congestive Heart Failure
Atacand
Candesartan

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012



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