EUCTR2011-001292-39-ES
Active, not recruiting
Phase 1
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years.A randomised, double-blind, multicentre, placebo controlled, phase II/III dose-finding study with a PK/PD characterisation and a 1 year efficacy/safety evaluation.
ab Servier0 sites116 target enrollmentAugust 7, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Paediatric dilated cardiomyopathy and symptomatic chronic heart failure
- Sponsor
- ab Servier
- Enrollment
- 116
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Patients of both gender aged from 6 months to less than 18 years old
- •\-Patients with dilated cardiomyopathy (DCM) receiving their usual treatment for chronic heart failure (CHF) at the optimal dose
- •\-Patients in sinus rhythm
- •Resting heart rate (HR) complying with the following criteria:
- •.HR \>\= 105 bpm in the age\-subset \[6\-12\[ months
- •.HR \>\= 95 bpm in the age\-subset \[1\-3\[ years
- •.HR \>\= 75 bpm in the age\-subset \[3\-5\[ years
- •.HR \>\= 70 bpm in the age\-subset \[5\-18\[ years.
- •\-CHF class II to IV NYHA or Ross classification, stable for at leas 1 month prior to selection
- •Left ventricular (LV) dysfunction with LVEF \<\= 45% documented by echocardiography
Exclusion Criteria
- •?Class I NYHA or Ross Classification (asymptomatic patients),
- •History of symptomatic or sustained (? 30 sec) ventricular arrhythmia unless a cardioverter defibrillator was implanted,
- •?Patients with structural valvular disease or severe functional valvular disease requiring surgery,
- •?Significant systemic ventricular outflow obstruction,
- •?DCM secondary to muscular dystrophies, hemoglobinopathies, HIV, carnitine deficiency,
- •?Patients requiring unauthorised concomitant treatment
- •?Serum creatinine \>2\.0 mg/dL or \>180 ?mol/L (blood sample performed at ASSE visit),
- •?AST and/or ALT \> 3 upper normal limits (blood sample performed at ASSE visit),
- •?Unstable cardiovascular conditionat selection or inclusion.
- •A girl having childbearing potential and sexually active not having contraception.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 yearsEUCTR2011-001292-39-DEInstitut de Recherches Internationales Servier90
Active, not recruiting
Not Applicable
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 yearsEUCTR2011-001292-39-HUInstitut de Recherches Internationales Servier90
Active, not recruiting
Not Applicable
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 yearsPaediatric dilated cardiomyopathy and symptomatic chronic heart failureMedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2011-001292-39-SEInstitut de Recherches Internationales Servier90
Active, not recruiting
Phase 1
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years.Paediatric dilated cardiomyopathy and symptomatic chronic heart failureMedDRA version: 16.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2011-001292-39-GBInstitut de Recherches Internationales Servier116
Active, not recruiting
Phase 1
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 yearsEUCTR2011-001292-39-BGInstitut de Recherches Internationales Servier90