Open Label Extension Study - Oral UT-15C for PAH

• Research type

  Research Study

• Full 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

• IRAS ID

  111681

• Contact name

  Gerry Coghlan

• Sponsor organisation

  United Therapeutics Corporation

• Eudract number

  2012-000098-21

• ISRCTN Number

  n/a

• Research summary

  Research Summary
  Open-Label Extension Study of UT-15C in Subjects with Pulmonary Arterial Hypertension - A Long-Term Follow-Up to Protocol TDE-PH-310. 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 purpose of this study is to assess how an investigational medication (UT-15C) works to treat pulmonary arterial hypertension and to allow for continued dosing of UT-15C in participants who successfully completed the predecessor study, TDE-PH-310. The study will be carried out in approximately 110 centres around the world with up to 858 participants that will be invited to participate. Upon completion of the TDE-PH-310 study, eligible patients will be told whether they were receiving the study medication (UT-15C) or the placebo. If they were receiving the study medication, they will continue to do so in the extension study. If they were receiving the placebo, they will stop taking the placebo and start taking the study medication during their participation in the extension study. The study will consist of a Baseline visit, followed by at least 2 separate visits over the first 12-week period. After the first 12 weeks, the participant will have a study visit once every 12 weeks until he/she discontinues from the study or the study ends. Similarly to the TDE-PH-310 study, the participants will undergo a number of procedures including a physical exam, blood tests and a 6 minute walk test throughout their time on the study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/1325

• Date of REC Opinion

  6 Nov 2012

• REC opinion

  Further Information Favourable Opinion