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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00147199
First received: September 2, 2005
Last updated: July 11, 2013
Last verified: July 2013
Results First Received: December 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Interventions: Drug: Inhaled treprostinil
Drug: Placebo inhalation solution

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided by United Therapeutics

Publications automatically indexed to this study:

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00147199     History of Changes
Other Study ID Numbers: LRX-TRIUMPH 001
Study First Received: September 2, 2005
Results First Received: December 3, 2012
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency