A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Arterial Hypertension (PAH)

Condition studied

Pulmonary Arterial Hypertension (PAH)

Investigational medicinal product(s)

Every trial of NS-863 across our registers →

Eligibility

Primary endpoint

Primary Efficacy Endpoint: Change in pulmonary vascular resistance (PVR) Primary Safety Endpoints: Number of participants who experienced an adverse event (AE) up to approximately 24 weeks

Endpoint detail

Secondary Efficacy Endpoints: •Change in hemodynamic parameters • Change in 6-minute walk distance (6MWD) •Change in Borg dyspnea scale • Change in Word Health Organization Functional Classification (WHO FC) • Change in echocardiogram • Change in PAH-Symptoms and Impact (SYMPACT®), Secondary Safety Endpoints: • Vital signs • Physical examinations • 12-lead electrocardiograms (ECGs) •Clinical laboratory tests (hematology, serum chemistry, urinalysis, and coagulation)