Ralinepag in PAH Patients

Condition: Pulmonary arterial hypertension

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Diagnosis of symptomatic World Health Organization Group 1 pulmonary arterial hypertension (PAH)
  • Has had a right heart catheterization performed at or within 365 days of screening that is consistent with the diagnosis of PAH

Key Exclusion Criteria

  • Body weight <40 kg
  • Body mass index (BMI) ≥40 kg/m2
  • PAH diagnosis ≥5 years at screening

Full Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to Pulmonary Arterial Hypertension (PAH) Standard of Care or PAH-Specific Background Therapy in Subjects With World Health Organization (WHO) Group 1 PAH (IRB no. 54816)    

Summary
The purpose of this study is to assess an investigational drug called ralinepag in the treatment of pulmonary arterial hypertension (PAH). PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. Researchers aim to determine how well ralinepag works when used with the current treatment for PAH, in addition to how it affects the ability to exercise, heart rate recovery (how quickly the heart rate slows down after a walking test) and quality of life. The study will also examine the effects of ralinepag, when used with the patient's current treatment for PAH, on blood test results and study assessments, as well as evaluate any side effects.

Phase
Phase III

Principal Investigator
Aaron Weinberg, MD

Contact
Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org