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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634400
• Other study ID #: SH-AHS-0003
• Secondary ID: D2454C00003
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2008
• Last updated: January 24, 2011
• Start date: March 1999
• Est. completion date: May 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute of PharmacyIceland: Icelandic Medicines Control AgencyIreland: Ministry of HealthItaly: Ministry of HealthMalaysia: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of HealthSingapore: Health Sciences AuthoritySouth Africa: Department of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicUnited 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 depressed left ventricular function

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6268
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• 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		2, 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		2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months