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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):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Intravenous Treprostinil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intravenous Treprostinil

Intravenous treprostinil was supplied as 1 mg/mL.

Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.


Participant Flow:   Overall Study
    Intravenous Treprostinil
STARTED   16 
COMPLETED   0 
NOT COMPLETED   16 
Adverse Event                2 
Withdrawal by Subject                4 
Death                6 
Physician Decision                1 
Study terminated by Sponsor                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intravenous Treprostinil

Intravenous treprostinil was supplied as 1 mg/mL.

Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.


Baseline Measures
   Intravenous Treprostinil 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.1  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  56.3% 
Male      7  43.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      16 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      16 100.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      0   0.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
India   16 


  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Leigh Peterson, PhD
Organization: United Therapeutics, Corp.
e-mail: lpeterson@unither.com



Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03055221     History of Changes
Other Study ID Numbers: RIV-PH-403
First Submitted: February 9, 2017
First Posted: February 16, 2017
Results First Submitted: March 20, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017