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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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)

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.

Detailed Summary:
Sponsor: United Therapeutics

Current Primary Outcome:

• Safety of Remodulin in Subjects with PAH as Assessed by the Number of Subjects with Treatment-related Adverse Events. [ Time Frame: Baseline to each subject's last visit, assessed up to approximately 9 years ]
• Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline to each subject's last visit, assessed up to approximately 9 years ]
  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 New York Heart Association (NYHA) Functional Classification [ Time Frame: Baseline to each subject's last visit, assessed up to approximately 9 years ]
  The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: United Therapeutics

Dates:
Date Received: February 9, 2017
Date Started: June 10, 2005
Date Completion:
Last Updated: February 13, 2017
Last Verified: February 2017