|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 January 2024 |
|
Main ID: |
NCT03055221 |
|
Date of registration:
|
09/02/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
TRUST-2 |
|
Scientific 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) |
|
Date of first enrolment:
|
June 10, 2005 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03055221 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Key inclusion & exclusion 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.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pulmonary Arterial Hypertension
|
|
Intervention(s)
|
|
Drug: Intravenous Treprostinil
|
|
Primary Outcome(s)
|
|
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
[Time Frame: 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 Subject Safety
[Time Frame: Baseline to Week 12]
|
|
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
[Time Frame: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit]
|
|
Secondary ID(s)
|
|
RIV-PH-403
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|