TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Phase 4

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Intravenous Treprostinil

• Registration Number: NCT03055221
• Lead Sponsor: United Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-10
• Primary Completion: 2014-02-25
• Study Completion: 2014-02-25
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Results First Submitted: 2017-03-20
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-27
• Results First Posted: 2017-07-28
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Treprostinil	Intravenous Treprostinil	Intravenous treprostinil was supplied as 1 mg/mL.

Primary Outcome Measures

Name	Time	Method
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)	The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit	The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Effect of Long-term Remodulin Therapy on Subject Safety	Baseline to Week 12	Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification	The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit	The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).