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

Phase 3

Completed

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

• Registration Number: NCT00634309
• Lead Sponsor: AstraZeneca

Brief Summary

A study to evaluate the effect of Atacand on patients with heart failure with depressed 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: 597

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
1	Candesartan	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality or hospitalisation due to congestive heart failure	2, 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	2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months