An Open-Label Extension Study of UT-15C in Subjects with Pulmonary Arterial Hypertension - A Long-Term Follow-Up to Protocol TDE-PH-310
- Conditions
- increased pressure in pulmonary arteriesPAH10057166
- Registration Number
- NL-OMON50371
- Lead Sponsor
- nited Therapeutics Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
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.
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 <p>The primary objective of this study is to provide UT-15C sustained release<br /><br>tablets for eligible subjects who participated in TDE-PH-310.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the long-term safety of oral UT-15C<br /><br>- To assess the effect of continued long-term therapy with UT-15C on exercise<br /><br>capacity (six minute walk distance [6MWD] Borg dyspnea score), World Health<br /><br>Organization (WHO) Functional Class, and N- terminal pro-brain natriuretic<br /><br>peptide (NT proBNP) (at Week 48 only)<br /><br><br /><br>Exploratory Objective: Optional evaluation of pharmacogenomics</p><br>