Trials / Terminated
TerminatedNCT02633293
An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 243 (actual)
- Sponsor
- United Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inhaled Treprostinil | Inhaled treprostinil up to 15 breaths (90 mcg) four times daily |
Timeline
- Start date
- 2016-09-15
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2015-12-17
- Last updated
- 2022-12-02
- Results posted
- 2022-12-02
Locations
92 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT02633293. Inclusion in this directory is not an endorsement.