Coronary Artery Disease MedDRA version: 14.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: PROCORALAN
Product Name: ivabradine
Product Code: S16257-2
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IVABRADINE
CAS Number: 155974-00-8
Current Sponsor code: S16257-2
Co
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, at least 30 years old at the date of selection to 75 years (inclusive) of age at the date of selection, - Patients with CAD documented - Patients with Type II diabetes documented, - Patients in sinus rhythm and with HR= 70 bpm on 12-lead ECG after 5 minutes rest, - Patients with brachial SBP/DBP =140/90 mmHg (mean of 3 measurements performed in supine position using a semi-automatic oscillometric device at 5 min intervals), - Normal (considering the patient disease) fasting lab test results for sampling performed between selection and inclusion visits, - Patients with stable and appropriate treatment (according to the investigator) with beta-blockers (at the exception of nebivolol and carvedilol), during at least 3 months before the selection visit. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Known severe renal disease, including renal failure or serum creatinine = 200 µM or µmol/L or 2.2 mg/dL, - Known moderate or severe hepatic disease including severe hepatic insufficiency and/ or severe liver function test abnormalities: ALT or AST > 3 times the upper reference limits, - Significant anaemia defined as blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females), - Fasting glucose > 13 mmol/L, - History of central neuropathy and/or of symptomatic orthostatic hypotension, - Severe hypotension at the time of selection (blood pressure < 90 / 50 mmHg), - Patient currently or previously treated with ivabradine within the last 3 months before selection visit, - Patient currently or previously treated with nebivolol or carvedilol within the last 3 months before selection visit, - Patients with recent (less than 3 months) MI or coronary revascularisation, - Patients with recent (less than 3 months) stroke or cerebral transient ischemic attack, - Patients scheduled for coronary revascularisation procedures (PCI or CABG)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ivabradine on central aortic systolic blood pressure (CASBP) in comparison to placebo in patients with stable CAD, type II diabetes, and a resting HR= 70 bpm, treated by beta-blockers.;Secondary Objective: To investigate the effect of ivabradine in comparison to placebo on: - other central and radial blood pressure and heart rate parameters obtained through applanation tonometry, - carotid-femoral pulse wave velocity (PWV), - skin capillary density, - brachial blood pressure parameters, - resting HR from 12-lead Electrocardiogram (ECG), - safety. ;Primary end point(s): Central aortic systolic blood pressure (CASBP);Timepoint(s) of evaluation of this end point: Measured at baseline and after 3weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Other central pressure parameters: Central aortic diastolic blood pressure (CADBP), augmentation index (AIx), augmentation pressure (Ao), aortic pulse pressure (PP), subendocardial viability ratio (SEVR) (Buckberg index), LV ejection time (LVET), - Radial blood pressure parameters: systolic blood pressure (SBP), diastolic blood pressure (DBP), radial pulse pressure (PP) - Heart rate derived from applanation tonometry during recording of central pressure parameters - Carotid-femoral pulse wave velocity (PWV) - Capillary density - Resting HR from 12 lead ECG - Supine brachial blood pressure parameters (SBP, DBP), - Safety profile ;Timepoint(s) of evaluation of this end point: - resting HR from ECG : at baseline, - safety profile : over all the sudy period, - other secondary endpoints : measured at baseline and after 3 weeks of treatment | — |
Countries
Ireland, Italy
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed