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NCT03254485 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
A Phase 2 study, sponsored by Akebia Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT03254485: Completed Phase 2 study, sponsored by Akebia Therapeutics.
NCT03254485 is a Phase 2 study that has completed, run by Akebia Therapeutics. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03254485, a Phase 2 study, has completed, sponsored by Akebia Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those adverse events (AEs) that started or worsened in severity after the administration of study drug. Causality relationship to study drug was per Investigator assessment. Number of participants with TEAEs and study drug-related TEAEs is pr
Interventions
- DRUG Placebo Oral Tablet
- DRUG IW-1973
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2019-08-19 |
| Phase | Phase 2 |
What the finished NCT03254485 record still lists
NCT03254485 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03254485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03254485 about?
NCT03254485 is a clinical study titled "A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)". The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or wi...
What is the current status of trial NCT03254485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2017-11-07. Estimated completion is 2019-08-19.
What interventions are being tested in trial NCT03254485?
The interventions under investigation include: Placebo Oral Tablet (DRUG), IW-1973 (DRUG).
Who is sponsoring clinical trial NCT03254485?
This trial is sponsored by Akebia Therapeutics, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03254485's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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