DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT

nited Therapeutics Corporation0 个研究点目标入组 450 人开始时间: 2009年5月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1) Eligible subjects who completed assessments in the final visit of the previous controlled trials (TDE-DU-201 and TDE-DU-301), and who signed appropriate informed consent, are eligible to enroll in this extension study.
•2) If a female of childbearing potential, the subject must agree to continue practicing an acceptable method of birth control (i.e. surgical sterilization, approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device).
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients must not:
•1) Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
•2) Have been found to be unable to complete study assessments in the previous controlled trial;
•3) Have prematurely discontinued study drug during the previous study (TDE-DU-201 or TDE-DU-301) due to treatment related adverse events

发起方

nited Therapeutics Corporation