An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Oral Treprostinil
Intervention description: Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 894.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil
      diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203,
      TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety
      of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise
      capacity after 1 year of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject remained on study drug and completed all assessments during the Treatment
             Phase of the previous study (TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE
             PH-302, or TDE-PH-308) OR the subject permanently discontinued study drug during the
             Treatment Phase of the previous study due to clinical worsening (as defined in the
             protocol of the previous study), completed premature termination assessments prior to
             discontinuing study drug, completed all remaining scheduled study visits, AND received
             placebo during the Treatment Phase of the previous studies OR the subject was
             randomized into Group 1 or Group 2 in Study TDE PH 202, permanently discontinued study
             drug during the 12-week Treatment Phase due to clinical worsening, completed all
             premature termination assessments prior to discontinuing study drug, and completed all
             remaining scheduled study visits and assessments (with the exception of the
             hemodynamic measurements) through Week 12. Such subjects should have started treatment
             with oral treprostinil in the open-label study at 0.25 mg twice daily (BID).

          2. The subject voluntarily gave informed consent to participate in the study.

          3. Women of childbearing potential includes any female who had experienced menarche and
             who had not undergone successful surgical sterilization (hysterectomy, bilateral tubal
             ligation, or bilateral oophorectomy) or was not postmenopausal (defined as amenorrhea
             for at least 12 consecutive months). Sexually active women of childbearing potential
             must have used 2 effective forms of contraception during the length of the study.
             Medically acceptable forms of effective contraception included: (1) approved hormonal
             contraceptives (such as birth control pills), (2) barrier methods (such as a condom or
             diaphragm) used with a spermicide, (3) an intrauterine device, (4) partner vasectomy,
             or (5) abstinence. Males participating in the study must have used a condom during the
             length of the study, and for at least 48 hours after discontinuing study medication.
             Protocol Amendment A.1AU included the required assessment for Austrian subjects to
             perform urine pregnancy tests every 4 weeks during the study.

        Exclusion Criteria:

          1. The subject permanently discontinued study drug during the previous study (TDE PH 202,
             TDE-PH-203, TDE PH 205, TDE-PH-301, TDE-PH-302, or TDE PH 308) due to
             treatment-related adverse events (AEs).

          2. The subject permanently discontinued study drug during the Treatment Phase of the
             previous study (TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, or
             TDE-PH-308) due to clinical worsening (as defined in those study protocols) and did
             not undergo premature termination assessments prior to discontinuing study drug,
             and/or did not complete all remaining study visits through the final scheduled visit.

          3. The subject prematurely discontinued study drug during the Treatment Phase of the
             previous study due to clinical worsening (as defined in those study protocols),
             completed premature termination assessments prior to discontinuing study drug,
             completed all remaining scheduled study visits AND received oral treprostinil during
             the Treatment Phase of the previous study (TDE PH-202, TDE-PH-203, TDE-PH-301,
             TDE-PH-302, or TDE PH-308). Subjects enrolled in Study TDE-PH-202 who were randomized
             into the individual maximum tolerated dose (iMTD) group who clinically worsened could
             not participate. Subjects who permanently discontinued study drug during the 12-week
             Treatment Phase due to treatment-related AEs were not eligible even if they completed
             all remaining scheduled study visits. Subjects who permanently discontinued study drug
             during the 12 week Treatment Phase and did not undergo premature termination
             assessments prior to discontinuing study drug and/or who did not complete all
             remaining study visits through the Week 12 visit were also not eligible.

          4. The subject developed any concurrent illness or condition during the conduct of the
             previous study, including but not restricted to: sleep apnea, chronic renal
             insufficiency, anemia, uncontrolled systemic hypertension, or left sided heart
             disease, unless their physician felt that entry into this study would not be
             detrimental to their overall health.