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: May 10, 2016
Last verified: May 2016

December 4, 2009
May 10, 2016
May 2006
December 2020   (final data collection date for primary outcome measure)
  • Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test [ Time Frame: Once, after one year of therapy with UT-15C SR. ] [ Designated as safety issue: No ]
  • Long-term safety as assessed by clinical laboratories [ Time Frame: Performed at each study scheduled visit ] [ Designated as safety issue: Yes ]
    After one year exposure to UT-15C clinical laboratorial assessments will occur 1 time/year through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.
  • Long-term safety as assessed by adverse events [ Time Frame: Performed monthly during monthly telephone calls ] [ Designated as safety issue: Yes ]
    Telephone calls will occur at a minimum 1 time/month through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.
  • 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 ]
Complete list of historical versions of study NCT01027949 on ClinicalTrials.gov Archive Site
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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, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment.
This is an open-label study. Each subject's visit schedule will allow assessments after defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by the appropriate regulatory authorities or the study is discontinued by the sponsor. Therefore, the actual date of each visit will be determined by the date on which the subject first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302, or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date of UT-15C SR initiation in this study for subjects who were randomized to placebo in the previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.
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 or thrice daily. Open label study with active drug, no other intervention arms.
Experimental: Treprostinil diethanolamine (UT-15C)
All open will receive active study drug
Intervention: Drug: Treprostinil diethanolamine
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*   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)
Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects must complete all assessments in one of these studies to be eligible.
Both
12 Years and older   (Child, Adult, Senior)
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
Czech Republic
 
NCT01027949
TDE-PH-304
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United Therapeutics
United Therapeutics
Not Provided
Study Director: Kevin Laliberte, PharmD United Therapeutics
United Therapeutics
May 2016

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