TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
TRUST-2
TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2005
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2014
CompletedFirst Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedResults Posted
Study results publicly available
July 28, 2017
CompletedJanuary 5, 2024
June 1, 2017
8.7 years
February 9, 2017
March 20, 2017
December 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Effect of Long-term Remodulin Therapy on Subject Safety
Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).
Baseline to Week 12
Study Arms (1)
Intravenous Treprostinil
EXPERIMENTALIntravenous treprostinil was supplied as 1 mg/mL.
Interventions
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Eligibility Criteria
You may qualify if:
- Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Information
- Organization
- United Therapeutics Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 16, 2017
Study Start
June 10, 2005
Primary Completion
February 25, 2014
Study Completion
February 25, 2014
Last Updated
January 5, 2024
Results First Posted
July 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share