Coronary Artery DiseasePhase 1VISORNCT03255512
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients
A Phase 1 study testing Vericiguat (BAY1021189) and Isosorbide mononitrate (ISMN) in people with Coronary Artery Disease, run by Bayer at 6 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Vericiguat (BAY1021189) and Isosorbide mononitrate (ISMN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 6 sitesGermany
- Study dates
- 17 Aug 2017to 23 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Universitätsherzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
Charité - Campus Virchow-Klinikum (CVK)
Berlin, 13353
Medizinische Einrichtungen der Universität Bonn
Bonn, North Rhine-Westphalia, 53105
SocraTec R&D GmbH
Erfurt, Thuringia, 99084
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
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
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Vericiguat (BAY1021189), Placebo, Isosorbide mononitrate (ISMN)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat (BAY1021189)Drug
2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet
PlaceboDrug
Matching placebo
Isosorbide mononitrate (ISMN)Drug
30 mg/tablet or 60 mg/tablet
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat + isosorbite mononitrate | Experimental | Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each,prior to start of vericiguat administration.
Then subjects received 2.5 mg vericiguat for about 14 days, followed by 5 mg vericiguat for about 14 days, followed by 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of vericiguat administration, taken 1 hour prior to vericiguat (in-house days) or together with vericiguat (out-patient days). Receives: Drug: Vericiguat (BAY1021189); Drug: Isosorbide mononitrate (ISMN) |
| Placebo + isosorbite mononitrate | Placebo comparator | Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each, prior to start of placebo administration.
Then subjects received placebo matching 2.5 mg vericiguat for about 14 days, followed by placebo matching 5 mg vericiguat for about 14 days, followed by placebo matching 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of placebo administration, taken 1 hour prior to placebo (in-house days) or together with placebo (out-patient days). Receives: Drug: Placebo; Drug: Isosorbide mononitrate (ISMN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 8 weeks
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start17 Aug 2017
- Primary completion7 Feb 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255512
- Sponsor's protocol ID
- 18582
- Other IDs
- 2016-005178-36, 2016
- Acronym
- VISOR
- Status last verified
- Dec 2021
- First submitted
- 3 Aug 2017
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boettcher M, Mikus G, Trenk D, Dungen HD, Donath F, Werner N, Karakas M, Besche N, Schulz-Burck D, Gerrits M, Hung J, Becker C. Vericiguat in combination with isosorbide mononitrate in patients with chronic coronary syndromes: The randomized, phase Ib, VISOR study. Clin Transl Sci. 2022 May;15(5):1204-1214. doi: 10.1111/cts.13238. Epub 2022 Mar 17.
PubMed 35299288
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03255512
- Acronym / sponsor ID
- VISOR / 18582
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat + isosorbite mononitrate | Experimental | Drug: Vericiguat (BAY1021189), Drug: Isosorbide mononitrate (ISMN)Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each,prior to start of vericiguat administration. Then subjects received 2.5 mg vericiguat for about 14 days, followed by 5 mg vericiguat for about 14 days, followed by 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of vericiguat administration, taken 1 hour prior to vericiguat (in-house days) or together with vericiguat (out-patient days). |
| Placebo + isosorbite mononitrate | Placebo comparator | Drug: Placebo, Drug: Isosorbide mononitrate (ISMN)Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each, prior to start of placebo administration. Then subjects received placebo matching 2.5 mg vericiguat for about 14 days, followed by placebo matching 5 mg vericiguat for about 14 days, followed by placebo matching 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of placebo administration, taken 1 hour prior to placebo (in-house days) or together with placebo (out-patient days). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vericiguat (BAY1021189)2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet | Drug | Vericiguat + isosorbite mononitrate |
| PlaceboMatching placebo | Drug | Placebo + isosorbite mononitrate |
| Isosorbide mononitrate (ISMN)30 mg/tablet or 60 mg/tablet | Drug | Placebo + isosorbite mononitrate, Vericiguat + isosorbite mononitrate |
Primary outcome
Blood pressure
Time frame: Up to 8 weeks
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.
Heart rate
Time frame: Up to 8 weeks
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.
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 35299288Boettcher M, Mikus G, Trenk D, Dungen HD, Donath F, Werner N, Karakas M, Besche N, Schulz-Burck D, Gerrits M, Hung J, Becker C. Vericiguat in combination with isosorbide mononitrate in patients with chronic coronary syndromes: The randomized, phase Ib, VISOR study. Clin Transl Sci. 2022 May;15(5):1204-1214. doi: 10.1111/cts.13238. Epub 2022 Mar 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vericiguat (BAY1021189) and Isosorbide mononitrate (ISMN) in people with Coronary Artery Disease, run by Bayer at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.