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NCT05532046 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT05532046: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT05532046 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05532046, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat people who have chronic heart failure. Chronic heart failure is a medical condition with shortness of breath, tiredness and ankle swelling in which the heart does not pump blood as well as it should. BAY2413555 is a new compound which is under development for the treatment of heart failure. Heart failure is a serious disease in which the heart pumps less well. BAY2413555 is expected to protect the heart and improve cardiac function. The main purpose of this study is to learn how safe BAY2413555 is compared to placebo in participants with chronic heart failure and implanted cardiac defibrillator, or cardiac resynchronization devices (ICD/CRT). A placebo is a treatment that looks like a medicine, but does not have any medicine in it. ICD/CRT are machines placed in the body that use an electric shock/impulse to reset the heart or get it beating correctly. To study the safety, the researchers will record all medical problems the participants may have during the study after starting the study treatment. Medical problems that happen after the participants have started their treatment are also known as "treatment emergent adverse events" (TEAEs). The TEAEs will be compared between participants who received BAY2413555 and those who received placebo. The second purpose of this study is to learn whether BAY2413555 effects electrical signals inside the heart compared to placebo. The study has two parts, A and B. Each part will last for two weeks. In part A, the participants will be assigned by chance to either take BAY2413555 as a tablet by mouth once per day or a placebo. Participants from part A who do not need to stop the study based on predefined criteria continue in part B. They will be assigned by chance to receive either the same dose of BAY2413555 as in part A or a higher dose. Participants who have taken placebo in part A will as well be assigned in part B. Each participant will be in the study for approximately 9
Interventions
- DRUG BAY2413555 Dose 1
- DRUG BAY2413555 Dose 2
- DRUG Placebo to BAY2413555
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
Why NCT05532046 stopped before completion
NCT05532046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which BAY2413555 Dose 1 is the first listed.
NCT05532046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05532046 about?
NCT05532046 is a clinical study titled "A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)". Researchers are looking for a better way to treat people who have chronic heart failure. Chronic heart failure is a medical condition with shortness of breath, tiredness and ankle swelling in which the heart does not pump blood as well as it should. BAY2413555 is a new compound which is under devel...
What is the current status of trial NCT05532046?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-09-20. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT05532046?
The interventions under investigation include: BAY2413555 Dose 1 (DRUG), BAY2413555 Dose 2 (DRUG), Placebo to BAY2413555 (DRUG).
Who is sponsoring clinical trial NCT05532046?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05532046's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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