An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)
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|ClinicalTrials.gov Identifier: NCT01027949|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2009
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Treprostinil diethanolamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension|
|Study Start Date :||May 2006|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Treprostinil diethanolamine (UT-15C)
All open will receive active study drug
Drug: Treprostinil diethanolamine
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.
- 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. ]
- Long-term safety as assessed by clinical laboratories [ Time Frame: Performed at each study scheduled visit ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027949
|Study Director:||Jeff Sigman||United Therapeutics|