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Remodulin® to Oral Treprostinil Transition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01588405
First received: January 6, 2012
Last updated: April 8, 2016
Last verified: April 2016
Results First Received: August 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: UT-15C SR

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
UT-15C SR UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.

Participant Flow:   Overall Study
    UT-15C SR  
STARTED     33  
COMPLETED     31  
NOT COMPLETED     2  
Adverse Event                 1  
Clinical Worsening                 1  



  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.
No text entered.

Reporting Groups
  Description
UT-15C SR UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.

Baseline Measures
    UT-15C SR  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Median (Full Range)
  50.0  
  (18 to 80)  
Gender  
[units: participants]
 
Female     25  
Male     8  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     2  
Asian     1  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     1  
White     28  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.   [ Time Frame: Up to 24 weeks ]

2.  Secondary:   Change From Baseline in Six-minute Walk Distance at Week 24   [ Time Frame: Baseline and week 24 ]

3.  Secondary:   Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24   [ Time Frame: Baseline and week 24 ]

4.  Secondary:   Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24   [ Time Frame: Baseline and week 24 ]

5.  Secondary:   Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Change in Dyspnea-fatigue Index From Baseline to Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)   [ Time Frame: Baseline and Week 24 ]

8.  Secondary:   Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)]   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)]   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)   [ Time Frame: Baseline and week 24 ]

11.  Secondary:   Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)   [ Time Frame: Baseline and Week 24 ]

12.  Secondary:   Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)   [ Time Frame: Baseline and week 24 ]

13.  Secondary:   Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)   [ Time Frame: Baseline and week 24 ]

14.  Secondary:   Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)   [ Time Frame: Baseline and week 24 ]

15.  Secondary:   Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)   [ Time Frame: Baseline and week 24 ]


  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: Nicole Leedom
Organization: United Therapeutics
phone: 919-425-5870
e-mail: nleedom@unither.com



Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01588405     History of Changes
Other Study ID Numbers: TDE-PH-205
Study First Received: January 6, 2012
Results First Received: August 20, 2015
Last Updated: April 8, 2016
Health Authority: United States: Food and Drug Administration