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)

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) - Bayer 18979

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46553

Enrollment

Registered

2018-02-27

Start date

2018-07-11

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular disease

Interventions

1. Name of active ingredient: Vericiguat: Dose(s): Treatment A: 2.5 mg vericiguat for 14 days (± 3 days) Treatment A*: 2.5 mg vericiguat for 14 days (± 3 days) Treatment B: 5 mg vericiguat for 14 days

400 mg moxifloxacin Route of administration: Once daily oral administration Duration of treatment: Single dose 3. Reference drug(s) Name of active ingredient: Placebo (Treatment D) Dose(s): 0 mg (ma

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Patients with stable CAD 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 (inclusive) * Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg/m²

Exclusion criteria

Exclusion criteria: * Ejection fraction (EF) below 30% at screening * Progressive angina with symptoms of worsening of angina within the

Design outcomes

Primary

Measure	Time frame
The primary variable is the time-matched placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) after 10 mg vericiguat at steady state Regular recordings of triplicate ECGs at baseline, on the first and on the last days of each treatment period and on Day 8 of the first and the last treatment period. Plasma concentrations of vericiguat at corresponding time points.	—

Measure

Time frame

The primary variable is the time-matched placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) after 10 mg vericiguat at steady state Regular recordings of triplicate ECGs at baseline, on the first and on the last days of each treatment period and on Day 8 of the first and the last treatment period. Plasma concentrations of vericiguat at corresponding time points.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)