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NCT04722484

A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Kidney Disease and in Age-, Weight- and Gender-matched Healthy Participants

Completed Phase 1 Last updated 25 January 2021
What this trial tests

Phase 1 trial testing Vericiguat (BAY1021189) in Heart Failure in 39 participants. Completed in 22 January 2015.

Timeline
12 June 2014
Primary endpoint
22 January 2015
22 January 2015

Quick facts

Lead sponsorBayer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment39
Start date12 June 2014
Primary completion22 January 2015
Estimated completion22 January 2015
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 79, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight. The participants stayed at the trial site for about 6 days. During this time, the doctors took blood and urine samples and checked the participants' health. About 7-14 days after the participants took vericiguat (BAY1021189), the researchers checked the participants' health again and asked about any medical problems they had.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Pharmacokinetic and Pharmacodynamic Profile of Vericiguat.
    Fritsch A, Meyer M, Blaustein RO, Trujillo ME, et al · · 2024 · cited 8× · PMID 38916717 · DOI 10.1007/s40262-024-01384-1

Verify or expand the search:

Other trials of Vericiguat (BAY1021189)

Trials testing the same drug.

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04722484.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing