Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease
- Conditions
- Stable coronary artery diseaseMedDRA version: 16.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001668-31-GB
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 842
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br> Secondary Objective: - To assess the safety profiles of the two formulations over a 12-month period;<br> - To assess the efficacy of the two formulations over 6 and 12-month periods;<br> - To assess the safety and efficacy of switching ivabradine formulations over a 3-month period;<br> - To assess in a subset of patients the pharmacokinetic (PK) profile and the cardiac safety from 24-hour Holter ECG of the two formulations.<br> ;Timepoint(s) of evaluation of this end point: M06
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: M06, M09 and M12;<br> Secondary end point(s): Safety endpoints:<br> - Occurrence of emergent adverse events over 12 months;<br> - Other safety criteria over 6 and 12 months (blood pressure, laboratory test parameters).<br> <br> Efficacy endpoints:<br> - HR change from baseline;<br> - Change in clinical symptoms.<br> <br> Other endpoints: <br> -For PK characterisation: concentration of ivabradine and its active metabolite.<br> - For Holter evaluation: HR change and abnormalities during awake and sleep periods.<br>