NCT03504982

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-17
• Primary completion: 2018-11-29
• Completion: 2019-02-26
• First posted: 2018-04-20
• Last updated: 2020-04-17

Locations

8 sites across 3 countries: Germany, Moldova, Netherlands