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NCT01939301 · ClinicalTrials.gov registry record · Phase 2
Nitric Oxide to Treat Pulmonary Embolism
A Phase 2 study of Pulmonary Embolism, sponsored by Indiana University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 4
- Study locations
NCT01939301: Completed Phase 2 study of Pulmonary Embolism, sponsored by Indiana University School of Medicine.
NCT01939301 is a Phase 2 study of Pulmonary Embolism that has completed, run by Indiana University School of Medicine. The registered enrollment target is 78 participants, below the 3,057-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01939301, a Phase 2 study of Pulmonary Embolism, has completed, sponsored by Indiana University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
Primary Outcome
Right ventricular (RV) function and viability assessed by the composite of normal RV size (\<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) \> 16 mm and normal right ventricular index of myocardial performance (RIMP) \< 0.40 using spectral Doppler or \< 0.55 using tissue Doppler) and normal fractional area change (FAC) (\> 33%) and a serum hsTnT \< 14pg/mL. Missing values will be considered normal.
Conditions Studied
Interventions
- DRUG Sham
- DRUG Inhaled Nitric Oxide
Study Locations (4)
Indiana
- Eskenazi Hospital - Indianapolis
- Indiana University Hospital - Indianapolis
- Methodist Hospital - Indianapolis
Mississippi
- University of Mississippi - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-10-31 |
| Phase | Phase 2 |
What the finished NCT01939301 record still lists
NCT01939301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 3,057-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT01939301 reports a single indexed study location in Indiana, Mississippi.
Frequently Asked Questions
What is clinical trial NCT01939301 about?
NCT01939301 is a clinical study titled "Nitric Oxide to Treat Pulmonary Embolism". This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
What is the current status of trial NCT01939301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2013-10. Estimated completion is 2016-10-31.
What conditions does trial NCT01939301 study?
This clinical trial studies the following conditions: Pulmonary Embolism.
What interventions are being tested in trial NCT01939301?
The interventions under investigation include: Sham (DRUG), Inhaled Nitric Oxide (DRUG).
Who is sponsoring clinical trial NCT01939301?
This trial is sponsored by Indiana University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01939301 being conducted?
This trial has 4 study locations across Indiana, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Embolism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01939301's enrollment target sits among peer trials
78 39th of 48 higher than 10 of 48 other Pulmonary Embolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Embolism 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.
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