An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2012-000098-21-GB
• Date of registration: 01/08/2012
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics Corporation
• Public title: An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension
• Scientific title: An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310
• Date of first enrolment: 06/11/2012
• Target sample size: 850
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000098-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Greece, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Singapore, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: Regulatory Department
• Affiliation: United Therapeutics Europe Ltd

• Name: Regulatory Department
• Affiliation: United Therapeutics Europe Ltd

Key inclusion & exclusion 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.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].
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.
Are the trial subjects under 18? no
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 694
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension
MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: treprostinil diethanolamine
CAS Number: 830354-48-8
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.125-

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: treprostinil diethanolamine
CAS Number: 830354-48-8
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: treprostinil diethanolamine
CAS Number: 830354-48-8
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: treprostinil diethanolamine
CAS Number: 830354-48-8
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: treprostin

Primary Outcome(s)

Secondary Objective: 1) To assess the long-term safety of UT-15C
2) To assess the effect of continued long-term therapy with UT-15C on exercise capacity (6MWD/Borg dyspnea score), WHO Functional Class, and plasma concentrations of NT-proBNP (Week 48 only)

Main Objective: The primary objective of this study is to provide UT-15C sustained release tablets for eligible subjects who participated in TDE-PH-310 (A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy).

Timepoint(s) of evaluation of this end point: Efficacy:
6MWT- baseline, week 6, week 12 and every 12 weeks thereafter, and at study termination visit
Borg Dysphea Score- Following each 6MWT
WHO functional Class- baseline, week 6, week 12 and every 12 weeks thereafter, and at study termination visit
N-terminal pro BNP- Baseline and week 48
Safety:
Vital signs- baseline and at all subsequent protocol-required visits
Physical examination- Baseline and study termination visit
Clinical Laboratory Assessments- Baseline, week 12, week 24 and at every other follow-up visit thereafter, and at the study termination visit
Adverse event assessments- captured from the time the ICF is signed and should be followed for up to 30 days after completion of the study termination visit

Primary end point(s): Clinical assessments - Efficacy and Safety

Secondary Outcome(s)

Secondary end point(s): N/a

Timepoint(s) of evaluation of this end point: N/a

Secondary ID(s)

TDE-PH-311

Source(s) of Monetary Support

United Therapeutics Corporation

Ethics review

Status: Approved
Approval date:
Contact: