Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients

Coronary Artery Disease Clinical Trial

— VISOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255512
• Other study ID #: 18582
• Secondary ID: 2016-005178-36
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: December 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 23, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Vericiguat (BAY1021189)
2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet
• Placebo
Matching placebo
• Isosorbide mononitrate (ISMN)
30 mg/tablet or 60 mg/tablet

Locations

Country	Name	City	State
Germany	Universitätsherzzentrum Freiburg - Bad Krozingen	Bad Krozingen	Baden-Württemberg
Germany	Charité - Campus Virchow-Klinikum (CVK)	Berlin
Germany	Medizinische Einrichtungen der Universität Bonn	Bonn	Nordrhein-Westfalen
Germany	SocraTec R&D GmbH	Erfurt	Thüringen
Germany	Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 8 weeks
Primary	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.	Up to 8 weeks
Secondary	Number of participants with adverse events		Up to 9 weeks

External Links

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