Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added) - Full Text View

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

MedlinePlus related topics:

Depression Heart Failure

ChemIDplus related topics:

Candesartan cilexetil CV 11974

U.S. FDA Resources

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

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

Study ID Numbers:	SH-AHS-0006, D2454C00006
First Received:	March 7, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00634309
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Congestive Heart Failure

Atacand

Candesartan

Study placed in the following topic categories:

Candesartan cilexetil

Heart Failure

Heart Diseases

Depression

Candesartan

Angiotensin II

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

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