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

United Therapeutics

Status and phase: Completed; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Intravenous Treprostinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT03055221

RIV-PH-403

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intravenous Treprostinil

Experimental group

Description:

Intravenous treprostinil was supplied as 1 mg/mL.

Treatment:

Drug: Intravenous Treprostinil