TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

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.

Completed

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous Treprostinil

Drug

Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.

Other names: Remodulin

Primary outcomes

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).
Effect of Long-term Remodulin Therapy on Subject Safety

Time frame: Baseline to Week 12

Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Registry information

Official study 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)

Acronym: TRUST-2

Important dates

Study start: 2005
Primary completion: 2014
Study completion: 2014
First posted: Feb 16, 2017
Registry last updated: Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed