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

Congestive Heart Failure Clinical Trial

Official title:

Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Preserved Left Ventricular Systolic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634712
• Other study ID #: SH-AHS-0007
• Secondary ID: D2454C00007
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2008
• Last updated: January 24, 2011
• Start date: June 1999
• Est. completion date: May 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Candesartan

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality or hospitalisation due to congestive heart failure		, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
Secondary	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