Health Condition 1: null- Pulmonary Arterial Hypertension
Conditions
Interventions
Intervention1: UT 15-C SR (Treprostinil diethanolamine): Dose escalation study
BID, until either UT-15C SR receives regulatory approval in a region or the study is discontinued by the sponsor, Oral.
Control Intervention1: NIL: NIL
Sponsors
United Therapeutics
ICON Clinical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) The subject has 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 other studies evaluating PAH)) OR The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302, or TDE-PH-308) due to clinical worsening, 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 study (TDE-PH-301, TDE-PH-302, or TDE-PH-308). OR The subject was randomized into Dose Group 1 or Dose Group 2 in the 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 start treatment with UT- 15C in the open-label study at 0.25 mg BID. 2) The subject voluntarily gives informed consent to participate in the study. 3) Women of child bearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea for at least 12 consecutive months]. Sexually active women of childbearing potential must use two effective forms of contraception during the length of the study. Medically acceptable forms of effective contraception include: (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 (IUD), (4) partner vasectomy, or (5) abstinence. Males participating in the study must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.
Exclusion criteria
Exclusion criteria: 1)The subject permanently discontinued study drug during the previous study (TDE-PH-301, TDE-PH-302, or TDE-PH-308) due to treatment related adverse events. 2) The subject permanently discontinued study drug during the Treatment Phase of the previous study (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 permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302, or TDE-PH-308) due to clinical worsening, completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits AND received UT-15C SR during the Treatment Phase of the previous study (TDE-PH-301, TDE-PH-302, or TDE-PH-308). 4) The subject must not have 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 feels that entry into this study would not be detrimental to their overall health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, Clinical laboratory parametersTimepoint: Adverse events, Clinical laboratory parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-Minute Walk Test, Borg Dyspnea ScoreTimepoint: conducted after each subject has completed one year of therapy with UT-15C SR | — |
Countries
Australia, Austria, Belgium, Canada, China, France, Germany, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom, United States of America
Contacts
Public ContactJohn Luke
ICON Clinical Research India Private Limited,
Outcome results
None listed