Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunction

Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunction. A 6 to 12-month randomised double blind parallel groups multicentre study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001689-13-CZ

Enrollment

700

Registered

2012-08-08

Start date

2012-11-08

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe chronic heart failure and reduced left ventricular ejection fraction MedDRA version: 16.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849

Interventions

Product Name: S16257 Product Code: S16257 Pharmaceutical Form: Prolonged-release capsule, hard INN or Proposed INN: IVABRADINE CAS Number: 155974-00-8 Current Sponsor code: S16257 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women or men; - Age = 18 years; - Symptomatic CHF, NYHA class II, III or IV for at least 6 weeks prior to selection; - CHF from all aetiologies except from congenital heart disease or from severe aortic or mitral valva disease; - Normal sinus rhythm; - Resting heart rate =75bpm; - Documented left ventricular systolic dysfunction. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 434 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 266

Exclusion criteria

Exclusion criteria: - Women who are pregnant, breast-feeding or women of childbearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estroprogestative or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study. - Contra-indication to ivabradine, ivabradine not recommended or not effective, or requirement for a not recommended concomitant treatment (cf ivabradine SmPC); - Previous cardiac transplantation or on list for cardiac transplantation; - Patient treated with ivabradine in the month preceding the selection.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period;Secondary Objective: - To assess the safety of the two formulations over a 12-month period; - To assess the efficacy of the two formulations over 6 and 12-month periods; - To assess the safety and efficacy of switching ivabradine formulations over a 3-month period; - To assess in a subset of patients the pharmacokinetic profile and the cardiac safety from 24-hour Holter ECG of the two formulations.;Primary end point(s): Occurrence of emergent adverse events over 6 months.;Timepoint(s) of evaluation of this end point: M06	—

Measure

Time frame

Main Objective: To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period;Secondary Objective: - To assess the safety of the two formulations over a 12-month period; - To assess the efficacy of the two formulations over 6 and 12-month periods; - To assess the safety and efficacy of switching ivabradine formulations over a 3-month period; - To assess in a subset of patients the pharmacokinetic profile and the cardiac safety from 24-hour Holter ECG of the two formulations.;Primary end point(s): Occurrence of emergent adverse events over 6 months.;Timepoint(s) of evaluation of this end point: M06

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Secondary

Measure	Time frame
Secondary end point(s): Safety endpoints: - Occurrence of emergent adverse events over 12 months; - Other safety criteria (blood pressure, laboratory test parameters). Efficacy endpoints: - HR change from baseline; - Change in clinical symptoms. Other endpoints: - For PK characterisation: concentration of ivabradine and its active metabolite; - For Holter evaluation: HR change and abnormalities during awake and sleep periods.;Timepoint(s) of evaluation of this end point: M06, M09 and M12	—

Measure

Time frame

Secondary end point(s): Safety endpoints: - Occurrence of emergent adverse events over 12 months; - Other safety criteria (blood pressure, laboratory test parameters). Efficacy endpoints: - HR change from baseline; - Change in clinical symptoms. Other endpoints: - For PK characterisation: concentration of ivabradine and its active metabolite; - For Holter evaluation: HR change and abnormalities during awake and sleep periods.;Timepoint(s) of evaluation of this end point: M06, M09 and M12

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Countries

Argentina, Brazil, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Malaysia, Philippines, Poland, Portugal, Russian Federation, Spain, Ukraine, Vietnam

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com33155.72.43.66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026