Trial Condition(s):

Coronary artery disease

Vericiguat drug-drug interaction study with isosorbite mononitrate in stable coronary artery disease patients (VISOR)

Bayer Identifier:

18582

ClinicalTrials.gov Identifier:

NCT03255512

EudraCT Number:

2016-005178-36

Study Completed

Trial Purpose

This study is intended to investigate the pharmacodynamic drug-drug interaction as well as the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable coronary artery disease.

Inclusion Criteria
Patients with stable CAD defined by 
 -  coronary artery stenosis in any of the 3 main coronary vessels > 50% documented by coronary angiography within last 36 months
 -  or history of myocardial infarction 
 -  Age: 30 to 80 years (inclusive) at the first screening examination 
 -  Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
Exclusion Criteria
-  Intervention e.g. revascularization by percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) during the last 3 months
 -  Progressive angina with symptoms of worsening of angina within the < 3 months prior to the first screening examination
 -  History of recent (< 6 months prior to the first screening examination) myocardial infarction or unstable angina
 -  Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
 -  Insulin dependent diabetes mellitus
 -  Clinically relevant cardiac ischemia at screening 
 -  Clinical significant persistent ischemia, which should be ruled out by clinical judgment of the investigator, based on medical history, available clinical data e.g. past angiograms or preexisting or current exercise testing with any imaging technique (e.g. dobutamine stress echocardiography, adenosine or dobutamine stress cardiac magnetic resonance imaging (CMR), scinthigraphy or exercise ECG)
 -  Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III 
 -  Systolic blood pressure below 110 or above 160 mmHg at first screening visit
 -  Diastolic blood pressure above 100 mmHg at first screening visit
 -  Heart rate below 50 or above 100 beats / min (taken from ECG measurement) at first screening visit
 -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m*2 at first screening visit

Trial Summary

Enrollment Goal
41
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Charité - Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

SocraTec R&D GmbH

Erfurt, Germany, 99084

Status
Completed
 
Locations

Universitätsherzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany, 79189

Status
Completed
 

Trial Design