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NCT03619213 · ClinicalTrials.gov registry record · Phase 3
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,263
- Enrollment target
NCT03619213: Completed Phase 3 study, sponsored by AstraZeneca.
NCT03619213 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 6,263 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (711% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03619213, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,263 participants
- Enrollment target
Study Summary
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.
Primary Outcome
Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Interventions
- DRUG Placebo
- DRUG Dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,263 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2022-03-27 |
| Phase | Phase 3 |
What the finished NCT03619213 record still lists
NCT03619213 is an interventional study that assigns participants to a tested intervention. Its 6,263 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 (711% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03619213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03619213 about?
NCT03619213 is a clinical study titled "Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.". This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments t...
What is the current status of trial NCT03619213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,263 participants. The study started on 2018-08-27. Estimated completion is 2022-03-27.
What interventions are being tested in trial NCT03619213?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT03619213?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03619213's enrollment target sits among peer trials
6,263 35th of 2000 higher than 1,966 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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