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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00634400

First received: March 7, 2008

Last updated: January 24, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

January 24, 2011

Start Date ^ICMJE

March 1999

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiovascular mortality or hospitalisation due to congestive heart failure [ Time Frame: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00634400 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Candesartan in Heart Fail. Assess. of Reduction in Mortality & Morbidity. Candesartan in Patients With Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function

Brief Summary

A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: Candesartan
Other Name: Atacand
Drug: Placebo
Other Name: Placebo

Study Arm (s)

Active Comparator: 1
Intervention: Drug: Candesartan
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

6268

Completion Date

May 2003

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00634400

Other Study ID Numbers ^ICMJE

SH-AHS-0003, D2454C00003

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Chris Granger, MD

Information Provided By

AstraZeneca

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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