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NCT03057951 · ClinicalTrials.gov registry record · Phase 3
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,988
- Enrollment target
NCT03057951: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT03057951 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 5,988 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (676% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03057951, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,988 participants
- Enrollment target
Study Summary
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction. Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine. Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
Primary Outcome
Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment
Interventions
- DRUG Placebo
- DRUG Empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,988 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2021-04-26 |
| Phase | Phase 3 |
What the finished NCT03057951 record still lists
NCT03057951 is an interventional study that assigns participants to a tested intervention. Its 5,988 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 (676% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03057951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03057951 about?
NCT03057951 is a clinical study titled "EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)". This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin low...
What is the current status of trial NCT03057951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,988 participants. The study started on 2017-03-02. Estimated completion is 2021-04-26.
What interventions are being tested in trial NCT03057951?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT03057951?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03057951's enrollment target sits among peer trials
5,988 40th of 2000 higher than 1,961 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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