Coronary Artery DiseasePhase 1VENICENCT02617550
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients
A Phase 1 study testing Vericiguat (BAY1021189) and Nitroglycerin in people with Coronary Artery Disease, run by Bayer at 6 sites in Germany.
Trial summary
This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. 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 Nitroglycerin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 6 sitesGermany
- Study dates
- 18 Nov 2015to 11 Aug 2016
- 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
- Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
- Female subjects must be of non-childbearing potential
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
- 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 or patients with stroke at more than 3 months prior with significant residual neurologic involvement
- Insulin dependent diabetes mellitus
- Clinically relevant cardiac ischemia
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- Clinical significant persistent ischemia
- Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III
- Systolic blood pressure below 110 or above 160 mmHg
- Diastolic blood pressure above 100 mmHg
- Heart rate below 50 or above 100 beats / min
- Estimated glomerular filtration rate < 30 mL/min/1.73m2
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Study site
Berlin, 13353
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Erfurt, Thuringia, 99084
Study site
Hamburg, 20251
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Wuppertal, North Rhine-Westphalia, 42283
About this study
Official title: Evaluation of the Effect of 0.4 mg Nitroglycerin Spray After Pretreatment With Multiple Once Daily Oral Doses of 2.5 mg, 5 mg and 10 mg Vericiguat (BAY 1021189) Each Given Over 14 ± 3 Days on Safety, Tolerability and Blood Pressure in a Multi-center, Randomized, Placebo-controlled, Double-blind Group Comparison Study in Stable Coronary Artery Disease (CAD) Patients Aged 30 to 80 Years
This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
- Conditions
- Coronary Artery Disease
- Being tested
- Vericiguat (BAY1021189), Placebo, Nitroglycerin
- 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
Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets
PlaceboDrug
Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].
NitroglycerinDrug
0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat [trough] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat [peak] or placebo) on day 13, day 27 and day 41
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat + Nitroglycerin | Experimental | Co-administration of vericiguat and nitroglycerin Receives: Drug: Vericiguat (BAY1021189); Drug: Nitroglycerin |
| Placebo + Nitroglycerin | Placebo comparator | Aministration of matching placebo and nitroglycerin. Receives: Drug: Placebo; Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as measure of safety and tolerability
Measured: approximately 1 year
Secondary outcomes (2)
Blood pressure
Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Measured: approximately 1 year
Heart rate
Regular measurement of heart rate (bpm) in supine, sitting and standing position.
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start18 Nov 2015
- Primary completion18 May 2016
- Study completion11 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 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
- NCT02617550
- Sponsor's protocol ID
- 17849
- Other IDs
- 2015-001444-11, 2015
- Acronym
- VENICE
- Status last verified
- Dec 2021
- First submitted
- 11 Nov 2015
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- Evaluation of the Effect of 0.4 mg Nitroglycerin Spray After Pretreatment With Multiple Once Daily Oral Doses of 2.5 mg, 5 mg and 10 mg Vericiguat (BAY 1021189) Each Given Over 14 ± 3 Days on Safety, Tolerability and Blood Pressure in a Multi-center, Randomized, Placebo-controlled, Double-blind Group Comparison Study in Stable Coronary Artery Disease (CAD) Patients Aged 30 to 80 Years
- ClinicalTrials.gov ID
- NCT02617550
- Acronym / sponsor ID
- VENICE / 17849
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 18 May 2016 (actual)
- Study completion
- 11 Aug 2016 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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 effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
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 + Nitroglycerin | Experimental | Drug: Vericiguat (BAY1021189), Drug: NitroglycerinCo-administration of vericiguat and nitroglycerin |
| Placebo + Nitroglycerin | Placebo comparator | Drug: Placebo, Drug: NitroglycerinAministration of matching placebo and nitroglycerin. |
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
- Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
- Female subjects must be of non-childbearing potential
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
- 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 or patients with stroke at more than 3 months prior 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)Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets | Drug | Vericiguat + Nitroglycerin |
| PlaceboPlacebo for 14 +/-3 days given as 1 or 2 tablets [o.d.]. | Drug | Placebo + Nitroglycerin |
| Nitroglycerin0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat [trough] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat [peak] or placebo) on day 13, day 27 and day 41 | Drug | Placebo + Nitroglycerin, Vericiguat + Nitroglycerin |
Primary outcome
Number of participants with adverse events as measure of safety and tolerability
Time frame: approximately 1 year
2 secondary outcomes
Blood pressure
Time frame: approximately 1 year
Heart rate
Time frame: approximately 1 year
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.
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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 Nitroglycerin 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?
Number of participants with adverse events as measure of safety and tolerability (time frame: approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.