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

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2012-000098-21-GB
• Lead Sponsor: nited Therapeutics Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 850

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified