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NCT02630316 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 326
- Enrollment target
NCT02630316: Completed Phase 2 study, sponsored by United Therapeutics.
NCT02630316 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 326 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02630316, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 326 participants
- Enrollment target
Study Summary
This was a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled 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 included 326 patients at approximately 120 clinical trial centers. The treatment phase of the study lasted approximately 16 weeks. Patients who completed all required assessments were eligible to enter an open-label, extension study (RIN-PH-202).
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 to Week 16, 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 six minutes. Peak exposure 6MWD will occur by conducting 6
Interventions
- DRUG Placebo
- DRUG Inhaled Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2017-02-03 |
| Est. Completion | 2019-12-26 |
| Phase | Phase 2 |
What the finished NCT02630316 record still lists
NCT02630316 is an interventional study that assigns participants to a tested intervention. The registered 326 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 (145% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02630316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02630316 about?
NCT02630316 is a clinical study titled "Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE". This was a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled 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 p...
What is the current status of trial NCT02630316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 326 participants. The study started on 2017-02-03. Estimated completion is 2019-12-26.
What interventions are being tested in trial NCT02630316?
The interventions under investigation include: Placebo (DRUG), Inhaled Treprostinil (DRUG).
Who is sponsoring clinical trial NCT02630316?
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 NCT02630316's enrollment target sits among peer trials
326 147th of 2000 higher than 1,853 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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