An Open-Label, Long-Term Study of Oral Treprostinil (study drug) in Subjects With Pulmonary Arterial Hypertension who completed 310 study.
- Conditions
- Health Condition 1: null- Pulmonary Arterial Hypertension
- Registration Number
- CTRI/2014/10/005123
- Lead Sponsor
- nited Therapeutics Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Participated in United Therapeutics Study TDE-PH-310.
1.The subject voluntarily provides informed consent to participate in the study.
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.Women of childbearing potential (WOCBP) must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two 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 (IUD), 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].
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.
A subject is not eligible to participate in this study if any of the following criteria apply:
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (e.g.number and frequency of adverse events, changes in laboratory parameters from Baseline)Timepoint: The primary objective for the study is to provide UT-15C for eligible subjects who participated in 310 study. Exercise capacity and WHO functional class will be assessed at all the visits and NT-proBNP will be assessed during baseline and week 48. <br/ ><br>Safety (e.g.number and frequency of adverse events, changes in laboratory parameters from Baseline)
- Secondary Outcome Measures
Name Time Method 1. Long term safety assessment of UT-15C <br/ ><br>2. Continued long-term therapy effect with UT-15C on exercise capacity (6MWD/Borg Dyspnea Score), WHO functional class and plasma concentrations of NT-pro-BNPTimepoint: 1.Long term safety assessment of UT-15C <br/ ><br>2. Week 48 only