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

NCT03504982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-04-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2018-11-29
Completion
2019-02-26

Countries

  • Germany
  • Moldova
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504982 on ClinicalTrials.gov