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Clinical trial

TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

ID
Name
RIV-PH-403
Description
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 arms
Trial start
2005-06-10
Estimated PCD
2014-02-25
Trial end
2014-02-25
Status
Completed
Phase
Early phase I
Treatment
Intravenous Treprostinil
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Arms:
Intravenous Treprostinil
Other names:
Remodulin
Size
20
Primary endpoint
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
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
Effect of Long-term Remodulin Therapy on Subject Safety
Baseline to Week 12
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-01-05

1 organization

1 product

1 indication

Product
Treprostinil
Indication
Pulmonary Arterial Hypertension
Organization
United Therapeutics