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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00634400
First received: March 7, 2008
Last updated: January 24, 2011
Last verified: January 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Cardiovascular Diseases
Heart Diseases
Candesartan
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014