APD811-303-A phase 3 OLE ext to evaluate long term safety of ralinepag
Research type
Research Study
Full title
A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION
IRAS ID
255904
Contact name
Luke Howard
Contact email
Sponsor organisation
Arena Pharmaceuticals , Inc.
Eudract number
2018-001189-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
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 open-label extension (OLE) study will evaluate the effect of the investigational study drug (ralinepag) over a longer period of time on the following:
• The symptoms of PAH
• The ability to exercise (during a walking test)
• The heart rate recovery (how quickly the heart rate slows down after a walking test)
• The blood test results and study assessments when used with the current treatment for PAH
• The quality of life
• Any side effects participants may have during the studyREC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0063
Date of REC Opinion
11 Mar 2019
REC opinion
Further Information Favourable Opinion