Phase 4
Completed N=20
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Source: ClinicalTrials.gov NCT03055221 ↗Enrolled (actual)
20
Serious AEs
87.5%
Results posted
Jul 2017
Primary outcomePrimary: Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) — 440.8 Meters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) |
440.8 | — |
| PRIMARY Effect of Long-term Remodulin Therapy on the NYHA Functional Classification |
2.1 | — |
| PRIMARY Effect of Long-term Remodulin Therapy on Subject Safety |
14 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)
Exclusion Criteria
- Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.
Data sourced from ClinicalTrials.gov (NCT03055221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.