APD811-301 A phase 3 study to evaluate ralinepag added to SOC in PAH
A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients
Arena Pharmaceuticals , Inc.
Duration of Study in the UK
3 years, 2 months, 26 days
The purpose of this research study is to assess an investigational medication called ralinepag (also referred to as the “investigational study drug”) in the treatment of pulmonary arterial hypertension (PAH). Ralinepag has not been approved by any regulatory authorities, including the US Food and Drug Administration (FDA), therefore, it is not available by prescription.
Participants in this study have been diagnosed with PAH.
PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. These narrow or blocked blood vessels make it harder for the blood to flow, which can cause the blood pressure in the lungs to increase and means that the heart will need to work harder to pump the blood to the lungs. Eventually, this can lead to a decreased function of the heart (heart failure).
This study will evaluate the following:
• How well the investigational study drug ralinepag works when used with the current treatment for PAH
• The effect of ralinepag, when used with the current treatment for PAH, on the ability to exercise (during a walking test)
• The effect of ralinepag, when used with the current treatment for PAH, on the heart rate recovery (how quickly the heart rate slows down after a walking test)
• The effect of ralinepag, when used with the current treatment for PAH, on the blood test results and study assessments
• The effect of ralinepag, when used with the current treatment for PAH, on the quality of life
• Any side effects that participants may have during the study.
London - Westminster Research Ethics Committee
Date of REC Opinion
11 Mar 2019
Further Information Favourable Opinion