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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00634712

First received: March 7, 2008

Last updated: January 24, 2011

Last verified: January 2011

History of Changes

Purpose

A study to evaluate the effect of Atacand on patients with heart failure with preserved 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 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Candesartan 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: , 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: Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI ]

Estimated Enrollment:	734
Study Start Date:	June 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634712

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Dr Salim Yusuf

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	NCT00634712 History of Changes
Other Study ID Numbers:	SH-AHS-0007, D2454C00007
Study First Received:	March 7, 2008
Last Updated:	January 24, 2011
Health Authority:	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 cilexetil
Candesartan
Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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