PAH Clinical Trial
Official title:
Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy
and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to
80 years of age with PAH.
The study will be performed in approximately 50 study centers across the United States of
America and Europe. The recruitment period is anticipated to be approximately 24 months.
Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the
study.
Study participation for each subject will last approximately 8 months. The study will consist
of a screening period (within 30 days prior to dosing), 180 days (approximately 6 months)
treatment period and approximately 14 days follow-up period after the end of treatment visit.
;
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