TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) (TRUST-2)
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|ClinicalTrials.gov Identifier: NCT03055221|
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Intravenous Treprostinil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||June 10, 2005|
|Primary Completion Date :||February 25, 2014|
|Study Completion Date :||February 25, 2014|
Resource links provided by the National Library of Medicine
U.S. FDA Resources
Experimental: Intravenous Treprostinil
Intravenous treprostinil was supplied as 1 mg/mL.
Drug: Intravenous Treprostinil
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Other Name: Remodulin
Primary Outcome Measures :
- 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 ]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 [ Time Frame: 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).
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