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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Intravenous Treprostinil Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03055221     History of Changes
Other Study ID Numbers: RIV-PH-403
First Posted: February 16, 2017    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by United Therapeutics:
Remodulin
6-Minute Walk Test

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents