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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00634712
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular function

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Candesartan Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 734 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 1999
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Drug: Candesartan
Other Name: Atacand
Placebo Comparator: 2 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular mortality or hospitalisation due to congestive heart failure [ Time Frame: , 4, 6 weeks, 6 months, every 4 months thereafter until 24 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634712


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Dr Salim Yusuf
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00634712    
Other Study ID Numbers: SH-AHS-0007
D2454C00007
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Congestive Heart Failure
Atacand
Candesartan
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Candesartan
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action