AzTrials
AzTrials

Coronary Artery DiseasePhase 1NCT03504982

Study to Evaluate the QT / QTc Interval Prolongation Potential of Vericiguat

A Phase 1 study testing Vericiguat (BAY1021189) and Moxifloxacin in people with Coronary Artery Disease, run by Bayer at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable CAD (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 Moxifloxacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
8 sitesin 3 countries
Study dates
17 May 2018to 26 Feb 2019
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 (coronary artery disease) defined by:
  • clinically stable for at least 3 months
  • coronary artery stenosis in any of the 3 main coronary vessels
  • or history of myocardial infarction
  • Sinus rhythm at screening
  • Interpretable echocardiographic images
  • Age: 30 to 80 years
  • Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg/m²

Who cannot join

  • Ejection fraction (EF) below 30% at screening
  • Progressive angina with symptoms of worsening of angina within the <3 month
  • History of recent myocardial infarction or unstable Angina
  • Documented current relevant coronary stenosis ≥90% in any of the main 3 coronary vessels without bypass graft
  • Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months or patients with stroke at more than 3 months
  • Insulin dependent diabetes mellitus
Show all 27Show fewer
  • Clinically significant and persisting cardiac ischemia
  • Atrial fibrillation, pacemaker, defibrillator, second and third degree atrial-ventricular (AV) block
  • Known clinically relevant ventricular arrhythmias
  • Clinically relevant heart failure with reduced left ventricular ejection fraction
  • Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis; any other moderate or severe valvular failures
  • Valve replacement
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Previous or imminent cardiac transplantation
  • Known long QT syndrome or prolongation of the QT interval with ongoing proarrhythmic conditions
  • Co-medication with drugs known to have QT prolonging effect
  • Intolerance of fluoroquinolones, including moxifloxacin
  • History of serious adverse effects e.g. tendinitis and tendon rupture, arthralgia and effects on the peripheral and central nervous system while taking fluoroquinolones including moxifloxacin
  • History of tendon diseases or tendon injury caused by quinolones
  • Treatment with fluoroquinolones, including moxifloxacin during the last 2 weeks
  • Treatment with organic nitrates during the last 3 months
  • Treatment with riociguat during the last 3 months
  • Treatment with phosphodiesterase (PDE)-5 inhibitors during the last 14 days
  • Systolic blood pressure below 110 or above 160 mmHg at screening visit
  • Diastolic blood pressure below 50 or above 100 mmHg at screening visit
  • Heart rate below 50 or above 100 beats/min (taken from ECG measurement) at first screening visit
  • Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m*2

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany6 sites

  • Universitätsherzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Charité Campus Virchow-Klinikum (CVK)

    Berlin, 13353

  • PAREXEL GmbH

    Berlin, 14050

  • Medizinische Einrichtungen der Universität Bonn

    Bonn, North Rhine-Westphalia, 53105

  • SocraTec R&D Clinical Ward

    Erfurt, Thuringia, 99084

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

Moldova1 site

  • IMSP Republican Clinical Hospital

    Chisinau, MD2025

Other trials in Moldova

Netherlands1 site

  • Center for Human Drug Research

    Leiden, 2333 CL

Other trials in Netherlands

About this study

Official title: Study to Clinically Evaluate the QT/QTc Interval Prolongation Potential of Vericiguat in Patients With Stable Coronary Artery Disease in a 2-arm, Placebo-controlled, Randomized, Double-blind, Double-dummy Design Including a Vericiguat Multiple-dose Part With Fixed up Titration Periods and Moxifloxacin as Positive Control (for Assay Sensitivity Testing, Nested Into the Placebo Treatment)

The primary objective of this study was to investigate whether there is a clinically meaningful effect on QTc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable CAD (coronary artery disease).

Being tested
Vericiguat (BAY1021189), Moxifloxacin, Placebo
Keywords
Vericiguat, Stable CAD, QT/QTc
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

    A : 2.5 mg vericiguat A*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C*: 10 mg vericiguat

  • MoxifloxacinDrug

    D: 400 mg moxifloxacin

  • PlaceboDrug

    A : vericiguat placebo 10 mg A*: vericiguat placebo 10 mg + moxifloxacin placebo B : vericiguat placebo 10 mg C : vericiguat placebo 2.5 mg C*: vericiguat placebo 2.5 mg + moxifloxacin placebo D : vericiguat placebo 2.5 mg + vericiguat placebo 10 mg

Study groups in NCT03504982
Study groupRoleWhat they receive
Treatment 1ExperimentalTreatment sequences: A*-B-C-D
Receives: Drug: Vericiguat (BAY1021189); Drug: Moxifloxacin; Drug: Placebo
Treatment 2ExperimentalTreatment sequences: D-A-B-C*
Receives: Drug: Vericiguat (BAY1021189); Drug: Moxifloxacin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-matched placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) after 10 mg vericiguat at steady state.

    Measured: Baseline, day 56 (steady state 10 mg) of vericiguat treatment

Secondary outcomes (13)

  1. Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 2.5 mg vericiguat

    Measured: Baseline and day 1 of vericiguat treatment

  2. Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 5 mg vericiguat

    Measured: Baseline and day 15 (+/- 3 days) of vericiguat treatment

  3. Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 10 mg vericiguat

    Measured: Baseline and day 29 (+/- 3 days) of vericiguat treatment

  4. Time-matched placebo-corrected change from baseline of QTcF after 2.5 mg vericiguat at steady state

    Measured: Baseline and day 14 (+/- 3 days) of vericiguat treatment (steady state 2.5 mg)

  5. Time-matched placebo-corrected change from baseline of QTcF after 5 mg vericiguat at steady state

    Measured: Baseline and day 28 (+/- 3 days) of vericiguat treatment (steady state 5 mg)

  6. Time-matched placebo-corrected change from baseline of QTcF after single dose of moxifloxacin

    Measured: Baseline and day 8 of the moxifloxacin treatment period

  7. Maximum concentration of vericiguat in plasma after first dose (Cmax)

    Measured: On profile day 1; Timeframe: 0 - 5 hours after dosing

  8. Time to maximum concentration of vericiguat in plasma after first dose (tmax)

    Measured: On profile day 1; Timeframe: 0 - 5 hours after dosing

  9. Maximum concentration of vericiguat in plasma after multiple doses (Cmax, md)

    Measured: On profile days: 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing

  10. Time to maximum concentration of vericiguat in plasma after multiple doses (tmax, md)

    Measured: On profile days: 1, 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing

  11. Maximum concentration of moxifloxacin in plasma after single dose (Cmax)

    Measured: On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing

  12. Time to maximum concentration of moxifloxacin in plasma after single dose (tmax)

    Measured: On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing

  13. Number of subjects with treatment-emergent adverse events (TEAEs)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start17 May 2018
  3. Primary completion29 Nov 2018
  4. Study completion26 Feb 2019

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504982
Sponsor's protocol ID
18979
Other IDs
2017-003094-33, 2017
Status last verified
Apr 2020
First submitted
13 Apr 2018
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ruehs H, Solms A, Frei M, Becker C, Trujillo ME, Garmann D, Meyer M. Assessing QTc Effects of Vericiguat Using Two Different Concentration-QTc Modeling Approaches. Clin Pharmacokinet. 2023 Nov;62(11):1639-1648. doi: 10.1007/s40262-023-01282-y. Epub 2023 Sep 6.

    PubMed 37672197

  • Bottcher M, Dungen HD, Corcea V, Donath F, Fuhr R, Gal P, Mikus G, Trenk D, Coenen M, Pires PV, Maschke C, Aliprantis AO, Besche N, Becker C. Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes. Am J Cardiovasc Drugs. 2023 Mar;23(2):145-155. doi: 10.1007/s40256-022-00557-2. Epub 2023 Jan 12.

    PubMed 36633816

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vericiguat (BAY1021189) and Moxifloxacin in people with Coronary Artery Disease, run by Bayer at 8 sites in 3 countries.

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 8 inclusion and 27 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Moldova, Netherlands. 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. 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?

Time-matched placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) after 10 mg vericiguat at steady state. (time frame: Baseline, day 56 (steady state 10 mg) of vericiguat treatment). 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 NCT03504982, which also lists 2 linked publications.

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 17 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in