Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)
ConditionPulmonary Arterial Hypertension
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNS Pharma, Inc.
About this trial
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)
Eligibility criteria
Qualifiers
Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials
Adult male or female participants 18 to 75 years of age at the time the ICF is signed
Idiopathic PAH (IPAH)
Heritable PAH (HPAH)
Disqualifiers
PAH associated with human immunodeficiency virus (HIV) infection
PAH associated with portal hypertension
PAH associated with schistosomiasis
PAH with features of venous/capillary involvement
Trial design
Treatments tested in this trial
- NS-863 Low Dose
- NS-863 High Dose
- NS-863 Placebo
Treatment groups
135 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
NS Pharma, Inc.
Lead sponsor
Nippon Shinyaku Co., Ltd.
Collaborator
Source ClinicalTrials.gov