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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
United Therapeutics

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE February 16, 2017
Results First Submitted Date  ICMJE March 20, 2017
Results First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 28, 2017
Actual Study Start Date  ICMJE June 10, 2005
Actual Primary Completion Date February 25, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Drug: Intravenous Treprostinil
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Other Name: Remodulin
Study Arms  ICMJE Experimental: Intravenous Treprostinil
Intravenous treprostinil was supplied as 1 mg/mL.
Intervention: Drug: Intravenous Treprostinil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 25, 2014
Actual Primary Completion Date February 25, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055221
Other Study ID Numbers  ICMJE RIV-PH-403
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party United Therapeutics
Study Sponsor  ICMJE United Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account United Therapeutics
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP