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

This study has been completed.

First Received: March 7, 2008 Last Updated: March 12, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00634712

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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: 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: , 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:	June 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Candesartan
2: Placebo Comparator	Drug: 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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	SH-AHS-0007, D2454C00007
Study First Received:	March 7, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00634712 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Congestive Heart Failure
Atacand
Candesartan

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Heart Failure
Heart Diseases

Candesartan
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Candesartan
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009