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Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477333
First Posted: November 22, 2011
Last Update Posted: March 6, 2017
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.
Information provided by (Responsible Party):
United Therapeutics
Results First Submitted: August 1, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: UT-15C SR
Drug: Tyvaso Inhalation Solution

  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
The recruitment period for this study was October 2011 to November 2013.

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 BID UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.

Participant Flow:   Overall Study
    UT-15C SR BID
STARTED   18 
COMPLETED   15 
NOT COMPLETED   3 
Adverse Event                1 
Withdrawal by Subject                1 
Clinical Deterioration                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 BID UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.

Baseline Measures
   UT-15C SR BID 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  77.8% 
>=65 years      4  22.2% 
Age 
[Units: Years]
Mean (Full Range)
 51.3 
 (20 to 70) 
Gender 
[Units: Participants]
Count of Participants
 
Female      13  72.2% 
Male      5  27.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  11.1% 
Not Hispanic or Latino      16  88.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      18 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures
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1.  Primary:   Change in Hemodynamic Parameters From Baseline to Week 24.   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.   [ Time Frame: Baseline and Week 24 ]

3.  Primary:   Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.   [ Time Frame: Baseline and Week 24 ]

4.  Primary:   Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.   [ Time Frame: Baseline and Week 24 ]

5.  Primary:   Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.   [ Time Frame: Baseline and Week 24 ]

6.  Primary:   Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.   [ Time Frame: Baseline and Weeks 4, 12, and 24 ]

8.  Secondary:   Time to Clinical Worsening Over the Treatment Period.   [ Time Frame: Clinical worsening was assessed continuously from Baseline through each subject’s last study visit ]

9.  Secondary:   Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.   [ Time Frame: Baseline and Weeks 4, 8, 12, and 24 ]

10.  Secondary:   N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.   [ Time Frame: Weeks 12 and 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: Kevin LaLiberte, PharmD
Organization: United Therapeutics Corp.
phone: 919-425-8176
e-mail: KLaliberte@unither.com



Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01477333     History of Changes
Other Study ID Numbers: TDE-PH-203
First Submitted: November 14, 2011
First Posted: November 22, 2011
Results First Submitted: August 1, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017