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

• Conditions: Pulmonary Arterial Hypertension; MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000098-21-IT
• Lead Sponsor: ITED THERAPEUTICS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 858

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 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 158

Exclusion Criteria

1.The subject is pregnant or lactating. 2.The subject is receiving infused or inhaled prostacyclin therapy. 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