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

Phase 3

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Placebo; Drug: Candesartan

• Registration Number: NCT00634712
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-06
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 734

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Candesartan	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality or hospitalisation due to congestive heart failure	, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI	Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI