Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with : 1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension
Conditions
Sponsors
United Therapeutics Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who remained on study drug and completed all assessments during the Treatment Phase of Study TDE-PH-301 or TDE-PH-302*. 2. Subjects who permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302*) due to clinical worsening, who completed premature termination assessments prior to discontinuing study drug, and who completed all remaining scheduled study visits, and who are revealed to have received placebo during the previous study (TDE-PH-301 or TDE-PH-302*). * At present it is not envisaged that Study TDE-PH-302 will be conducted in Ireland Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who did not complete all assessments during the Treatement Phase of Study TDE-PH 301 or TDE-PH-302*. 2. Subjects who permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-301 or TDE-PH-302*) due to clinical worsening, who completed premature termination assessments prior to discontinuing study drug, and who completed all remaining scheduled study visits, and who are revealed to have received active drug during the previous study (TDE-PH-301 or TDE-PH-302*) are not eligible for entry into this study as the subject previously clinically worsened on active drug. 3. Subjects who permanently discontinued study drug during the previous study (TDE-PH-301 or TDE-PH-302*) due to treatment related adverse events, even if they completed all remaining study visits in the previous study. * At present it is not envisaged that Study TDE-PH-302 will be conducted in Ireland
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302*. [* Please note: At present it is not envisaged that Study TDE-PH-302 will be conducted in Ireland];Secondary Objective: -Assess the long-term safety of UT-15C SR in these subjects through assessment of adverse events and laboratory parameters. -Assess the effect of continued therapy with UT-15C SR on exercise capacity after one year of treatment. ;Primary end point(s): The primary endpoint of the study is change in 6-Minute Walk Distance after for 12 months treatment | — |
Countries
Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed