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NCT02633293 · ClinicalTrials.gov registry record · Phase 2
An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
A Phase 2 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 243
- Enrollment target
NCT02633293: Clinical Trial Phase 2 study, sponsored by United Therapeutics.
NCT02633293 is a Phase 2 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 243 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633293, a Phase 2 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 243 participants
- Enrollment target
Study Summary
This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).
Primary Outcome
The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for 6 minutes. Distance \<500 meters suggests considerable exercise limita
Interventions
- DRUG Inhaled Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2016-09-15 |
| Est. Completion | 2021-08-01 |
| Phase | Phase 2 |
Why NCT02633293 stopped before completion
NCT02633293 is an interventional study that assigns participants to a tested intervention. The registered 243 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 (83% higher).
The record links to 0 conditions, and to 1 intervention - of which Inhaled Treprostinil is the first listed.
NCT02633293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02633293 about?
NCT02633293 is a clinical study titled "An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE". This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 ...
What is the current status of trial NCT02633293?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 243 participants. The study started on 2016-09-15. Estimated completion is 2021-08-01.
What interventions are being tested in trial NCT02633293?
The interventions under investigation include: Inhaled Treprostinil (DRUG).
Who is sponsoring clinical trial NCT02633293?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02633293's enrollment target sits among peer trials
243 236th of 2000 higher than 1,764 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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