Coronary artery disease MedDRA version: 18.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Code: RLX030
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: SERELAXIN
Current Sponsor code: RLX030
Sponsors
Novartis Pharma Service AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients =18 years of age, with body weight =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Previous treatment with serelaxin (also known as: RLX030, relaxin) • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. • Current or planned dialysis. • Impaired renal function during screening defined as an estimated glomerular filtration rate (eGFR) at screening and prior to treatment of 50 on prior or current echocardiogram], severe aortic regurgitation, or severe mitral stenosis). • Clinical diagnosis of acute coronary syndrome (ACS) including unstable angina within 30 days prior to screening as determined by both clinical and enzymatic criteria • Troponin elevation and dynamics indicative of ACS at any time between screening and randomization. • Previous myocardial infarction within 3 months of screening • History of Coronary Artery Bypass Graft (CABG) surgery • Heart failure due to significant arrhythmias (including any of the following: ventricular tachycardia, bradyarrhythmias with ventricular rate 120 beats per minute) • Any surgical or medical condition which in the opinion of the investigator may place the patient at higher risk from his/her participation in the study (e.g., history of poor tolerance of adenosine or 3 vessel coronary disease) • Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the effects on the coronary vasculature, as assessed by myocardial perfusion/coronary flow reserve, at the end of treatment (EoT) of 48 hours i.v. administration of 30 µg/kg/24h serelaxin or placebo in patients with coronary artery disease • To evaluate the effects on augmentation index (AIx) at the end of treatment (EoT) of 48 hours i.v. administration of 30 µg/kg/24h serelaxin or placebo in patients with coronary artery disease ; Secondary Objective: • To evaluate the effects on aortic distensibility by MRI and pulse wave velocity (PWV) by Sphygmocor , at the end of treatment (EoT) of 48 hours i.v. administration of 30 µg/kg/24h serelaxin or placebo in patients with coronary artery disease • To evaluate the effects on augmentation index (AIx) and pulse wave velocity (PWV) by Sphygmocor at the end of treatment (EoT) of 48 hours i.v. administration of 30µg/kg/24h serelaxin or placebo and at Day 30 and Day 180 • To assess the safety and tolerability of 48 hours i.v. infusion of serelaxin in patients with coronary artery disease • To assess the pharmacokinetics of 48 hours i.v. administration of 30 µg/kg/24h serelaxin infusion in patients with coronary artery disease ; Primary end point(s): - Change from baseline in microvascular function assessed by regional and global determinations of myocardial perfusion - Change from baseline in macrovascular function assessed by augmentation index (AIx) ; Timepoint(s) of evaluation of this end point: respectively at: -At pre-dose on Day 1 (baseline) and prior to the end of the 48 hour drug infusion -From pre-dose on Day 1 (baseline) until prior to the end of the 48h drug infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in aortic distensibility 2. Change from baseline in augmentation index 3. Change from baseline in pulse wave velocity 4. Number of participants with adverse events, serious adverse events, and death 5. Serum concentration of serelaxin 6. Serum concentration of ntibodies to serelaxin 7. Systemic clearance of serelaxin ; Timepoint(s) of evaluation of this end point: 1. 2. 3. At pre-dose on day 1 (baseline) until Day 180 after the start of drug infusion 4. From the screening visit until Day 180 5. 6. From pre-dose on Day 1 until Day 30 after the start of drug infusion 7. From pre-dose on Day 1 until 48h after the start of drug infusion. | — |
Countries
United Kingdom
Contacts
Public ContactMedical Collaboration Centre
Novartis Pharmaceuticals UK Limited
Outcome results
None listed