To provide UT-15C for eligible subjects who participated in study protocol TDE-PH-310
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to provide UT-15C sustained release
tablets for eligible subjects who participated in TDE-PH-310.
Secondary outcome
- 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
Background summary
Pulmonary arterial hypertension (PAH), defined as an elevation in pulmonary
arterial pressure and pulmonary vascular resistance, is a severe hemodynamic
abnormality common to a variety of diseases and syndromes. Elevation in
pulmonary arterial pressure causes an increase in right ventricular afterload,
impairing right ventricular function and ultimately leading to heart failure
and death.
The typical etiologies of PAH include idiopathic, heritable or associated with
collagen vascular/connective tissue disease, portal hypertension, infection
with the human immunodeficiency virus (HIV), a history of cocaine inhalation,
or exposure to appetite suppressant drugs. An estimated annual incidence of
approximately 2 cases per million has been reported for idiopathic PAH. [Rich,
1987; Rubin 1997]
There are three major factors thought to contribute to the increased pulmonary
vascular resistance seen in this disease: vasoconstriction, remodeling of the
vessel wall, and thrombosis. There are a number of metabolic pathways which
contribute to these changes that involve vasoactive mediators such as the
vasodilators nitric oxide and prostacyclin, and the vasoconstrictor
endothelin-1. These substances affect both vascular tone and remodeling leading
to their use as pharmacologic targets. [Farber, 2004]
Approved pharmacotherapies for PAH include: (1) intravenous prostacyclin
(epoprostenol sodium or Flolan®); (2) the prostacyclin analogues, subcutaneous
(SC), intravenous (IV), and inhaled treprostinil sodium (Remodulin®; Tyvaso®)
and inhaled iloprost (Ventavis®); (3) the
oral phosphodiesterase-5 inhibitors (PDE5-I), tadalafil (Adcirca®) and
sildenafil (Revatio®); and (4) the oral endothelin receptor antagonists,
bosentan (Tracleer®) and ambrisentan (Letairis®, Volibris®) [Barst, 2009].
Study objective
To provide UT-15C for eligible subjects who participated in study protocol
TDE-PH-310
Study design
Multi-center, open-label study for eligible patients who participated in
TDE-PH-310.
Intervention
/
Study burden and risks
/
T.W. Alexander Drive 55
Research Triangle Park, NC 27709
US
T.W. Alexander Drive 55
Research Triangle Park, NC 27709
US
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201200009821-NL |
| ClinicalTrials.gov | NCT01560637 |
| CCMO | NL41022.029.12 |