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Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

This study has been completed.
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
ronald oudiz, m.d., Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01268553
First received: December 29, 2010
Last updated: August 31, 2017
Last verified: August 2017
Results First Received: June 6, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Treprostinil

  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
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Reporting Groups
  Description
Open Label Single Arm Group World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids

Participant Flow:   Overall Study
    Open Label Single Arm Group
STARTED   6 
COMPLETED   6 
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.
No text entered.

Reporting Groups
  Description
Open Label Single Arm Group World Health Organization (WHO) group 1 PAH patients receiving long-term parenteral prostanoids

Baseline Measures
   Open Label Single Arm Group 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 9 
   50  (17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 9 
Female      8  88.9% 
Male      1  11.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 9 
United States   9 
pulmonary vascular resistance [1] 
[Units: Wood Units]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 6 
   4.2  (2.4) 
[1] 3 screen failures
6-minute walk distance [1] 
[Units: Meters]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 6 
   334  (132) 
[1] 3 screen failures
peak oxygen consumption [1] 
[Units: L/min]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 6 
   1.0  (0.2) 
[1] 3 screen failures
ratio of minute ventilation to CO2 output [1] 
[Units: Ratio]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 6 
   32  (2) 
[1] 3 screen failures
The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 6 
   6.8  (6) 
[1] CAMPHOR is a questionnaire that measures quality of life of patients with pulmonary hypertension using units on a scale, 0-25, higher = worse
[2] 3 screen failures


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Without Adverse Events   [ Time Frame: 12 Weeks ]

2.  Secondary:   Number of Participants Without Clinical Worsening   [ Time Frame: 12 weeks ]

3.  Secondary:   Change in 6-minute Walk Distance   [ Time Frame: 12 weeks ]

4.  Secondary:   VE/VCO   [ Time Frame: 12 weeks ]

5.  Secondary:   CAMPHOR: Cambridge Pulmonary Hypertension Outcome Review; Construct = Quality of Life   [ Time Frame: 12 q=weeks ]

6.  Secondary:   N-terminal Pro BNP Level   [ Time Frame: 12 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Ronald Oudiz
Organization: Los Angeles Biomedical research INst at Harbor-UCLA
phone: 310-222-3560 ext 310
e-mail: roudiz@labiomed.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ronald oudiz, m.d., Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01268553     History of Changes
Other Study ID Numbers: Tyvaso Switch
Study First Received: December 29, 2010
Results First Received: June 6, 2017
Last Updated: August 31, 2017