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
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
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 April 17, 2014