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

April 16, 2020 updated by: Bayer

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum (CVK)
      • Berlin, Germany, 14050
        • PAREXEL GmbH
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
        • Universitätsherzzentrum Freiburg - Bad Krozingen
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
        • Medizinische Einrichtungen der Universität Bonn
    • Thüringen
      • Erfurt, Thüringen, Germany, 99084
        • SocraTec R&D Clinical Ward
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD2025
        • IMSP Republican Clinical Hospital
  • Netherlands
      • Leiden, Netherlands, 2333 CL
        • Center for Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment 1
Treatment sequences: A*-B-C-D
Drug: Vericiguat (BAY1021189)
A : 2.5 mg vericiguat A*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C*: 10 mg vericiguat
Drug: Moxifloxacin
D: 400 mg moxifloxacin
Drug: Placebo
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
Experimental: Treatment 2
Treatment sequences: D-A-B-C*
Drug: Vericiguat (BAY1021189)
A : 2.5 mg vericiguat A*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C*: 10 mg vericiguat
Drug: Moxifloxacin
D: 400 mg moxifloxacin
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Baseline, day 56 (steady state 10 mg) of vericiguat treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 2.5 mg vericiguat
Time Frame: Baseline and day 1 of vericiguat treatment
Baseline and day 1 of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 5 mg vericiguat
Time Frame: Baseline and day 15 (+/- 3 days) of vericiguat treatment
Baseline and day 15 (+/- 3 days) of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 1st dose of 10 mg vericiguat
Time Frame: Baseline and day 29 (+/- 3 days) of vericiguat treatment
Baseline and day 29 (+/- 3 days) of vericiguat treatment
Time-matched placebo-corrected change from baseline of QTcF after 2.5 mg vericiguat at steady state
Time Frame: Baseline and day 14 (+/- 3 days) of vericiguat treatment (steady state 2.5 mg)
Baseline and day 14 (+/- 3 days) of vericiguat treatment (steady state 2.5 mg)
Time-matched placebo-corrected change from baseline of QTcF after 5 mg vericiguat at steady state
Time Frame: Baseline and day 28 (+/- 3 days) of vericiguat treatment (steady state 5 mg)
Baseline and day 28 (+/- 3 days) of vericiguat treatment (steady state 5 mg)
Time-matched placebo-corrected change from baseline of QTcF after single dose of moxifloxacin
Time Frame: Baseline and day 8 of the moxifloxacin treatment period
Baseline and day 8 of the moxifloxacin treatment period
Maximum concentration of vericiguat in plasma after first dose (Cmax)
Time Frame: On profile day 1; Timeframe: 0 - 5 hours after dosing
On profile day 1; Timeframe: 0 - 5 hours after dosing
Time to maximum concentration of vericiguat in plasma after first dose (tmax)
Time Frame: On profile day 1; Timeframe: 0 - 5 hours after dosing
On profile day 1; Timeframe: 0 - 5 hours after dosing
Maximum concentration of vericiguat in plasma after multiple doses (Cmax, md)
Time Frame: On profile days: 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing
On profile days: 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing
Time to maximum concentration of vericiguat in plasma after multiple doses (tmax, md)
Time Frame: On profile days: 1, 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing
On profile days: 1, 8, 14, 15, 28, 29, 42, 43, 50 and 56; Timeframe: 0 - 5 hours after dosing
Maximum concentration of moxifloxacin in plasma after single dose (Cmax)
Time Frame: On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing
On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing
Time to maximum concentration of moxifloxacin in plasma after single dose (tmax)
Time Frame: On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing
On moxifloxacin profile days (day 8 and 50); Timeframe: 0 - 5 hours after dosing
Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18979
  • 2017-003094-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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