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NCT04435626 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,016
- Enrollment target
NCT04435626: Completed Phase 3 study, sponsored by Bayer.
NCT04435626 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 6,016 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (679% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04435626, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,016 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
Primary Outcome
Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Interventions
- OTHER Placebo
- DRUG Finerenone (BAY94-8862)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,016 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2024-06-14 |
| Phase | Phase 3 |
What the finished NCT04435626 record still lists
NCT04435626 is an interventional study that assigns participants to a tested intervention. Its 6,016 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (679% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04435626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04435626 about?
NCT04435626 is a clinical study titled "Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%". The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization ...
What is the current status of trial NCT04435626?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,016 participants. The study started on 2020-09-14. Estimated completion is 2024-06-14.
What interventions are being tested in trial NCT04435626?
The interventions under investigation include: Placebo (OTHER), Finerenone (BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT04435626?
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 NCT04435626's enrollment target sits among peer trials
6,016 37th of 2000 higher than 1,964 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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