Trial Condition(s):
Study to evaluate the QT / QTc interval prolongation potential of vericiguat
18979
Not Available
The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTc interval in patients with stable CAD (coronary artery disease).
- Patients with stable CAD (coronary artery disease) defined by: -- clinically stable for at least 3 months -- coronary artery stenosis in any of the 3 main coronary vessels -- or history of myocardial infarction - Sinus rhythm at screening - Interpretable echocardiographic images - Age: 30 to 80 years - Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg/m²
- Ejection fraction (EF) below 30% at screening - Progressive angina with symptoms of worsening of angina within the <3 month - History of recent myocardial infarction or unstable Angina - Documented current relevant coronary stenosis ≥90% in any of the main 3 coronary vessels without bypass graft - Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months or patients with stroke at more than 3 months - Insulin dependent diabetes mellitus - Clinically significant and persisting cardiac ischemia - Atrial fibrillation, pacemaker, defibrillator, second and third degree atrial-ventricular (AV) block - Known clinically relevant ventricular arrhythmias - Clinically relevant heart failure with reduced left ventricular ejection fraction - Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis; any other moderate or severe valvular failures - Valve replacement - Hypertrophic obstructive cardiomyopathy (HOCM) - Previous or imminent cardiac transplantation - Known long QT syndrome or prolongation of the QT interval with ongoing proarrhythmic conditions - Co-medication with drugs known to have QT prolonging effect - Intolerance of fluoroquinolones, including moxifloxacin - History of serious adverse effects e.g. tendinitis and tendon rupture, arthralgia and effects on the peripheral and central nervous system while taking fluoroquinolones including moxifloxacin - History of tendon diseases or tendon injury caused by quinolones - Treatment with fluoroquinolones, including moxifloxacin during the last 2 weeks - Treatment with organic nitrates during the last 3 months - Treatment with riociguat during the last 3 months - Treatment with phosphodiesterase (PDE)-5 inhibitors during the last 14 days - Systolic blood pressure below 110 or above 160 mmHg at screening visit - Diastolic blood pressure below 50 or above 100 mmHg at screening visit - Heart rate below 50 or above 100 beats/min (taken from ECG measurement) at first screening visit - Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m*2
Locations | |
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Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SocraTec R&D Clinical Ward Erfurt, Germany, 99084 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsherzzentrum Freiburg - Bad Krozingen Bad Krozingen, Germany, 79189 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations PAREXEL GmbH Berlin, Germany, 14050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Center for Human Drug Research Leiden, Netherlands, 2333 CL | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IMSP Republican Clinical Hospital Chisinau, Moldova, MD2025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Not Available