check_circleStudy Completed
Coronary Artery Disease
Bayer Identifier:
18582
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Vericiguat drug-drug interaction study with isosorbite mononitrate in stable coronary artery disease patients
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.
Key Participants Requirements
Sex
AllAge
30 - 80 YearsTrial summary
Enrollment Goal
41Trial Dates
August 2017 - March 2018Phase
Phase 1Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medizinische Einrichtungen der Universität Bonn | Bonn, 53105, Germany |
Completed | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69120, Germany |
Completed | Charité - Campus Virchow-Klinikum (CVK) | Berlin, 13353, Germany |
Withdrawn | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |
Completed | SocraTec R&D GmbH | Erfurt, 99084, Germany |
Completed | Universitätsherzzentrum Freiburg - Bad Krozingen | Bad Krozingen, 79189, Germany |
Primary Outcome
- Blood pressureRegular measurements of blood pressure after a vericiguat administration on the first and on the last days of each dose step of vericiguat, and on the first days of ISMN up-titration.date_rangeTime Frame:Up to 8 weeks
- Heart rateRegular measurements heart rate after a vericiguat administration on the first and on the last days of each dose step of vericiguat, and on the first days of ISMN up-titration.date_rangeTime Frame:Up to 8 weeks
Secondary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:Up to 9 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2