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A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01934582
First received: August 29, 2013
Last updated: September 6, 2016
Last verified: September 2016
Results First Received: July 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: UT-15C SR
Drug: treprostinil diethanolamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Open-label Extension PK Population The PK population included all subjects enrolled in the PK substudy having met the study criteria who received at least 1 treatment of open-label treprostinil diethanolamine.

Participant Flow:   Overall Study
    Open-label Extension PK Population
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Open-label Extension PK Population The PK population included all subjects enrolled in the PK substudy having met the study criteria, who had sufficient treprostinil concentration-time data to derive noncompartmental PK parameters for at least 1 treatment of open-label treprostinil diethanolamine.

Baseline Measures
   Open-label Extension PK Population 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   6 
Age 
[Units: Years]
Mean (Full Range)
 60.6 
 (38 to 71) 
Gender 
[Units: Participants]
 
Female   11 
Male   2 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   13 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   12 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures
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1.  Primary:   To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).   [ Time Frame: Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2) ]

2.  Primary:   To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35   [ Time Frame: Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2) ]

3.  Primary:   To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).   [ Time Frame: Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2) ]

4.  Secondary:   To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose.   [ Time Frame: The 6MWT was conducted during BID dosing PK collection (up to 14 days prior to transitioning to TID dosing regimen [PK Visit 1]) and during TID dosing PK collection (up to 35 days after transitioning to TID dosing regimen [PK Visit 2]). ]

5.  Secondary:   To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.   [ Time Frame: The AEs were recorded for up to 50 days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Kevin Laliberte, PharmD
Organization: United Therapeutics Corp.
phone: 919-425-8176
e-mail: KLaliberte@unither.com



Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01934582     History of Changes
Other Study ID Numbers: TDE-PH-309
TDE-PH-304
Study First Received: August 29, 2013
Results First Received: July 14, 2016
Last Updated: September 6, 2016
Health Authority: United States: Food and Drug Administration