NCT03504982

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 coronary-artery-disease

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1 coronary-artery-disease

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 13, 2018

Last Update Submit

April 16, 2020

Conditions

Coronary Artery Disease

Keywords

VericiguatStable CADQT/QTc

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (13)

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

    Baseline and day 1 of vericiguat treatment

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

    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

    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

    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

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

  • +8 more secondary outcomes

Study Arms (2)

Treatment 1

EXPERIMENTAL

Treatment sequences: A\*-B-C-D

Drug: Vericiguat (BAY1021189)Drug: MoxifloxacinDrug: Placebo

Treatment 2

EXPERIMENTAL

Treatment sequences: D-A-B-C\*

Drug: Vericiguat (BAY1021189)Drug: MoxifloxacinDrug: Placebo

Interventions

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

Treatment 1Treatment 2
MoxifloxacinDRUG

D: 400 mg moxifloxacin

Treatment 1Treatment 2
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

Treatment 1Treatment 2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Universitätsherzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Medizinische Einrichtungen der Universität Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

SocraTec R&D Clinical Ward

Erfurt, Thuringia, 99084, Germany

Location

Charité Campus Virchow-Klinikum (CVK)

Berlin, 13353, Germany

Location

PAREXEL GmbH

Berlin, 14050, Germany

Location

IMSP Republican Clinical Hospital

Chisinau, MD2025, Moldova

Location

Center for Human Drug Research

Leiden, 2333 CL, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 37672197DERIVED

  • 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.

    PMID: 36633816DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

vericiguatMoxifloxacin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 20, 2018

Study Start

May 17, 2018

Primary Completion

November 29, 2018

Study Completion

February 26, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

MO(1)NL(1)DE(6)