Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease

Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease. A 6 to 12-month randomised double blind parallel groups multicentre study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001668-31-GB

Enrollment

850

Registered

2012-08-13

Start date

2012-10-05

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Stable coronary artery disease MedDRA version: 16.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: S16257 Product Code: S16257 Pharmaceutical Form: Prolonged-release capsule, hard INN or Proposed INN: IVABRADINE CAS Numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women or men; - Age = 18 years; - Documented stable CAD with or without chronic stable angina pectoris; - Normal sinus rhythm; - Resting heart rate = 60bpm. 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 374 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 326

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) - Heart failure patients with NYHA functional classification II, III or IV.

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;Primary end point(s): Occurrence of emergent adverse events over 6 months; Secondary Objective: - To assess the safety profiles 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 (PK) profile and the cardiac safety from 24-hour Holter ECG of the two formulations. ;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;Primary end point(s): Occurrence of emergent adverse events over 6 months; Secondary Objective: - To assess the safety profiles 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 (PK) profile and the cardiac safety from 24-hour Holter ECG of the two formulations. ;Timepoint(s) of evaluation of this end point: M06

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: M06, M09 and M12; Secondary end point(s): Safety endpoints: - Occurrence of emergent adverse events over 12 months; - Other safety criteria over 6 and 12 months (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.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: M06, M09 and M12; Secondary end point(s): Safety endpoints: - Occurrence of emergent adverse events over 12 months; - Other safety criteria over 6 and 12 months (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.

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Countries

Argentina, Bulgaria, Germany, Hungary, Italy, Korea, Republic of, Malaysia, Netherlands, Philippines, Russian Federation, Singapore, Slovakia, Spain, Ukraine, United Kingdom, 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