Back to resultsTRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) (TRUST-2)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravenous Treprostinil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Remodulin, 6-Minute Walk Test
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intravenous Treprostinil
Arm Description
Intravenous treprostinil was supplied as 1 mg/mL.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03055221
Brief Title
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Acronym
TRUST-2
Official Title
TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 10, 2005 (Actual)
Primary Completion Date
February 25, 2014 (Actual)
Study Completion Date
February 25, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Remodulin, 6-Minute Walk Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Treprostinil
Arm Type
Experimental
Arm Description
Intravenous treprostinil was supplied as 1 mg/mL.
Intervention Type
Drug
Intervention Name(s)
Intravenous Treprostinil
Other Intervention Name(s)
Remodulin
Intervention Description
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Primary Outcome Measure Information:
Title
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
Description
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Time Frame
The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Title
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
Description
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Time Frame
The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
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