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

Pulmonary Arterial Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055221
• Other study ID #: RIV-PH-403
• Status: Completed
• Phase: Phase 4
• Start date: June 10, 2005
• Est. completion date: February 25, 2014

Study information

• Verified date: June 2017
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 25, 2014
• Est. primary completion date: February 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Primary	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).	The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Primary	Effect of Long-term Remodulin Therapy on Subject Safety	Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).	Baseline to Week 12