An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01027949
First received: December 4, 2009
Last updated: March 7, 2014
Last verified: March 2014

December 4, 2009
March 7, 2014
May 2006
December 2020   (final data collection date for primary outcome measure)
  • Six-Minute Walk Distance [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Long-term safety as assessed by clinical laboratories [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Long-term safety as assessed by adverse events [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01027949 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

This study provides UT-15C (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed the TDE-PH-301, TDE-PH-302 or TDE-PH-308 studies. The purpose of this study is to assess the long term safety of UT-15C and to assess the effects of continued treatment with UT-15C on exercise capacity after one year of treatment.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Treprostinil diethanolamine
Oral sustained release tablet, twice daily
Experimental: Open label UT-15C
Intervention: Drug: Treprostinil diethanolamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
Not Provided
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of TDE-PH-301, TDE-PH-302 or TDE-PH-308

Exclusion Criteria:

  • Premature discontinuation of TDE-PH-301, TDE-PH-302 or TDE-PH-308
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   India,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Spain,   Sweden,   United Kingdom
 
NCT01027949
TDE-PH-304
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Study Director: Kevin Laliberte, PharmD United Therapeutics
United Therapeutics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP