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

This study has been completed.

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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00634309

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 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 Depressed Left Ventricular Systolic Function

Resource links provided by NLM:

MedlinePlus related topics: Depression 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: 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:	597
Study Start Date:	July 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: NCT00634309

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Prof. JJV McMurray

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-0006, D2454C00006
Study First Received:	March 7, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00634309 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Congestive Heart Failure
Atacand
Candesartan

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 February 08, 2010