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Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) (TRIUMPH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00147199
First Posted: September 7, 2005
Last Update Posted: August 12, 2013
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: December 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Interventions: Drug: Inhaled treprostinil
Drug: Placebo 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 first subject was enrolled on 7 June 2005 and the last subject exited the study on 12 Oct 2007.

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
Inhaled Treprostinil Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
Placebo Identical placebo inhalation solution

Participant Flow:   Overall Study
    Inhaled Treprostinil   Placebo
STARTED   115   120 
COMPLETED   102   110 
NOT COMPLETED   13   10 



  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
Inhaled Treprostinil Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
Placebo Identical placebo inhalation solution
Total Total of all reporting groups

Baseline Measures
   Inhaled Treprostinil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   120   235 
Age 
[Units: Years]
Mean (Full Range)
 55 
 (20 to 75) 
 52 
 (18 to 75) 
 54 
 (18 to 75) 
Gender 
[Units: Participants]
     
Female   93   98   191 
Male   22   22   44 
PAH Etiology 
[Units: Participants]
     
Idiopathic PAH (IPAH)   64   67   131 
Connective Tissue Disease (CTD)   40   37   77 
Other   11   16   27 
Background PAH Therapy 
[Units: Participants]
     
Bosentan   77   88   165 
Sildenafil   38   32   70 
Time on Background Therapy 
[Units: Weeks]
Mean (Standard Deviation)
     
Bosentan   98  (79)   90  (75)   94  (77) 
Sildenafil   65  (60)   77  (69)   70  (64) 
Baseline NYHA Class 
[Units: Participants]
     
Class III   112   118   230 
Class IV   3   2   5 
Baseline Six-Minute Walk Distance (6MWD) 
[Units: Meters]
Mean (Standard Deviation)
 346  (63)   351  (69)   348  (66) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak 6-minute Walk Distance   [ Time Frame: 12 weeks ]

2.  Secondary:   Clinical Worsening Events   [ Time Frame: 12 weeks ]

3.  Secondary:   Borg Dyspnea Score   [ Time Frame: 12 weeks ]

4.  Secondary:   New York Heart Association (NYHA) Functional Classification   [ Time Frame: 12 weeks ]

5.  Secondary:   Trough 6MWD at Week 12   [ Time Frame: 12 Weeks ]

6.  Secondary:   Peak 6MWD at Week 6   [ Time Frame: 6 weeks ]

7.  Secondary:   Quality of Life (Minnesota Living With Heart Failure)   [ Time Frame: 12 weeks ]

8.  Secondary:   Change in Signs and Symptoms of PAH   [ Time Frame: 12 weeks ]

9.  Secondary:   N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)   [ 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 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: Inhaled Treprostinil Program Head
Organization: United Therapeutics
phone: 919-485-8350
e-mail: clinicalrecordsmanagement@unither.com


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

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00147199     History of Changes
Other Study ID Numbers: LRX-TRIUMPH 001
First Submitted: September 2, 2005
First Posted: September 7, 2005
Results First Submitted: December 3, 2012
Results First Posted: August 12, 2013
Last Update Posted: August 12, 2013