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NCT03448419 · ClinicalTrials.gov registry record · Phase 3
This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
NCT03448419: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT03448419 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 312 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03448419, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test in patients with chronic HF with reduced ejection fraction (LVEF ≤ 40%) Secondary objectives are to assess Patient-Reported Outcome (PRO)
Primary Outcome
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. If repeated 6MWT measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the v
Interventions
- DRUG Placebo
- DRUG Empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2019-10-07 |
| Phase | Phase 3 |
What the finished NCT03448419 record still lists
NCT03448419 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03448419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03448419 about?
NCT03448419 is a clinical study titled "This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms". The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test in patients with chronic HF with reduced ejection fraction (LVEF ≤ 40%) Secondary objectives are to assess Patient-Reported Outcome (PRO)
What is the current status of trial NCT03448419?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2018-03-20. Estimated completion is 2019-10-07.
What interventions are being tested in trial NCT03448419?
The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT03448419?
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 NCT03448419's enrollment target sits among peer trials
312 1102nd of 2000 higher than 895 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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