Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 October 2021 |
Main ID: |
EUCTR2011-001292-39-ES |
Date of registration:
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07/08/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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. |
Date of first enrolment:
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22/11/2011 |
Target sample size:
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90 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001292-39 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Brazil
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Bulgaria
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Denmark
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Finland
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Germany
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Hungary
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Italy
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Mexico
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Portugal
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Russian Federation
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Departamento I+D
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Address:
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Avda. de los Madroños, 33
28043
Madrid
Spain |
Telephone:
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00+3491 748 9675 |
Email:
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ana.anorbe@netgrs.com |
Affiliation:
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Lab Servier |
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Name:
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Departamento I+D
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Address:
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Avda. de los Madroños, 33
28043
Madrid
Spain |
Telephone:
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00+3491 748 9675 |
Email:
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ana.anorbe@netgrs.com |
Affiliation:
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Lab Servier |
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Key inclusion & exclusion criteria
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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 LV dysfunction consecutive to idiopathic DCM, post-viral myocarditis DCM or ischaemic DCM, left ventricular non compaction with DCM as primary condition or post anthracyclines DCM (provided the treatment by anthracyclines was stopped at least two years prior to the selection into the study) Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Paediatric dilated cardiomyopathy and symptomatic chronic heart failure MedDRA version: 14.1
Level: LLT
Classification code 10008908
Term: Chronic heart failure
System Organ Class: 10007541 - Cardiac disorders
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Intervention(s)
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Trade Name: Procoralan Product Name: S16257-2 Product Code: S16527-2 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: PROCORALAN Product Name: S16257-2 Product Code: S16257-2 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine CAS Number: 155974-008 Current Sponsor code: S16257-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: PROCORALAN Product Name: S16257-2 Product Code: S16257-2 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257-2 Other descriptive name: SUB08357MIG Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Procoralan Product Name: S16257-2 Product Code: S16257-2 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Procoralan Product Name: S16257-2 Product Code: S16257-2 Pharmaceutical Form: Oral solution INN or Proposed INN: Ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257-2 Concentration un
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Primary Outcome(s)
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Main Objective: To determine the optimal dose of ivabradine to reach the target heart rate reduction (HRR) of 20% without inducing a bradycardia (i.e. HR should be greater than a predefined HR threshold by age subset) and/or signs or symptoms related to bradycardia, To assess the pharmacokinetic (PK) parameters of ivabradine and its active metabolite S 18982 after repeated oral administrations, To assess the PKPD relationship of ivabradine and its active metabolite S 18982 using heart rate as evaluation criterion.
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Secondary Objective: To assess, compared to placebo, the effects of ivabradine at target dose, on: .left ventricular ejection fraction, measured by echocardiography, .clinical symptoms by using the NYHA/ROSS classification, .global clinical status evaluated by the investigator/parents, .cardiovascular biomarker by measuring NT-proBNP, To assess, compared to placebo, the long-term safety of ivabradine over 1-year.
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Timepoint(s) of evaluation of this end point: PK measurements: at D014 and M000 Heart rate reduction (HRR): HR measurements during titration period (D000, D014, D028, D042, D056, M000)
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Primary end point(s): -Characterization PK and PKPD -Target HR achievement
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: over the study
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Secondary end point(s): -Echocardiographic parameters -Heart failure symptoms severity -Cardiovascular biomarker NT- proBNP. -Safety
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Secondary ID(s)
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2011-001292-39-FI
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CL2-16257-090
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ISRCTN60567801
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Source(s) of Monetary Support
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Lab Servier
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Ethics review
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Status: Approved
Approval date: 11/11/2011
Contact:
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