check_circleStudy Completed
Coronary Artery Disease
Bayer Identifier:infoA unique number for a trial given by Bayer.
18582
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
41The overall number of participants needed for a trial.
Trial Dates info
August 2017 - March 2018Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
YesA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Verquvo (Vericiguat, BAY1021189)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where 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Withdrawn | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |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 OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Number of participants with adverse eventsdate_rangeTime Frame:Up to 9 weeks
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.