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

January 24, 2011 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6268

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Active Comparator: 1
Drug: Candesartan
Other Names:
  • Atacand

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Chris Granger, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-AHS-0003
  • D2454C00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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