check_circleStudy Completed

Coronary Artery Disease

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

All

Age

30 - 80 Years

Trial summary

Enrollment Goal
41
Trial Dates
August 2017 - March 2018
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Charité - Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Withdrawn
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany
Completed
SocraTec R&D GmbHErfurt, 99084, Germany
Completed
Universitätsherzzentrum Freiburg - Bad KrozingenBad Krozingen, 79189, Germany

Primary Outcome

  • Blood pressure
    Regular 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 rate
    Regular 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 events
    date_rangeTime Frame:
    Up to 9 weeks

Trial design

Multi-center, randomized, placebo-controlled, double-blind group comparison study to investigate safety, tolerability and blood pressure of 2.5 mg, 5.0 mg and 10 mg vericiguat each given over 14 ± 3 days together with isosorbite mononitrate (ISMN) 60 mg extended release formulation after a pretreatment phase (ISMN-starting dose: 30 mg) in stable coronary artery disease (CAD) patients with or without heart failure aged 30 to 80 years - Vericiguat ISOsoRbite mononitrate interaction (VISOR) study
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2