increased pressure in pulmonary arteries PAH
Conditions
Interventions
None listed
Sponsors
United Therapeutics Corp
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily provides informed consent to participate in the study. 2. The subject participated in study TDE-PH-310 and met the definition of clinical worsening (as specified in Protocol TDE PH 310), remained on study drug, was compliant with study procedures and assessments during the TDE-PH-310 Study or was currently enrolled in that study at the time the study was discontinued by the sponsor. 3. All WOCBP must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use 2 different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. 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 or (4) partner vasectomy. For women of childbearing potential, a negative urine pregnancy test is required at Baseline (study entry) prior to initiating study medication. WOCBP includes 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]. 4. Males participating in the study must use a condom during the length of the study, and for at least 48 hours after their last dose of study medication.
Exclusion criteria
Exclusion criteria: 1. The subject is pregnant or lactating. 2. The subject has received infused or inhaled prostacyclin therapy for 29 days or more. 3. The subject was prematurely discontinued from study TDE-PH-310 for reasons other than a clinical worsening event. 4. The subject developed a concurrent illness or condition during the conduct of TDE PH 310 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to provide UT-15C sustained release tablets for eligible subjects who participated in TDE-PH-310. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the long-term safety of oral UT-15C - To assess the effect of continued long-term therapy with UT-15C on exercise capacity (six minute walk distance [6MWD] Borg dyspnea score), World Health Organization (WHO) Functional Class, and N- terminal pro-brain natriuretic peptide (NT proBNP) (at Week 48 only) Exploratory Objective: Optional evaluation of pharmacogenomics | — |
Countries
Netherlands
Outcome results
None listed