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NCT02188784 · ClinicalTrials.gov registry record · Phase 3
Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure
A Phase 3 study, sponsored by Adrian Hernandez.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT02188784: Completed Phase 3 study, sponsored by Adrian Hernandez.
NCT02188784 is a Phase 3 study that has completed, run by Adrian Hernandez. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02188784, a Phase 3 study, has completed, sponsored by Adrian Hernandez.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks. Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral placebo, therapy with oral Fe polysaccharide will be associated with improvement in functional capacity at 16 weeks as assessed by CPET.
Primary Outcome
To determine if oral Fe (Iron) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.
Interventions
- DRUG Polysaccharide Iron Complex 150 mg
- DRUG Placebo (for Polysaccharide Iron Complex)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2014-09-03 |
| Est. Completion | 2016-04-06 |
| Phase | Phase 3 |
What the finished NCT02188784 record still lists
NCT02188784 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Polysaccharide Iron Complex 150 mg is the first listed.
NCT02188784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02188784 about?
NCT02188784 is a clinical study titled "Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure". The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Redu...
What is the current status of trial NCT02188784?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2014-09-03. Estimated completion is 2016-04-06.
What interventions are being tested in trial NCT02188784?
The interventions under investigation include: Polysaccharide Iron Complex 150 mg (DRUG), Placebo (for Polysaccharide Iron Complex) (DRUG).
Who is sponsoring clinical trial NCT02188784?
This trial is sponsored by Adrian Hernandez, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02188784's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 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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