Trial Condition(s):
Study to evaluate the QT / QTc interval prolongation potential of vericiguat
18979
Not Available
The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state 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 | Status | |
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Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charité - Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SocraTec R&D GmbH Erfurt, Germany, 99084 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsherzzentrum Freiburg - Bad Krozingen Bad Krozingen, Germany, 79189 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations PAREXEL GmbH Berlin, Germany, 14050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Center for Human Drug Research Leiden, Netherlands, 2333 CL | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IMSP Republican Clinical Hospital Chisinau, Moldova, MD2025 | Status Completed | 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