Ralinepag Phase II Open-Label Extension Study in Patients with Pulmonary Arterial Hypertension.

ABSTRACT:

Introduction

Ralinepag is a potent, titratable, orally administered prostacyclin (IP) receptor agonist to treat pulmonary arterial hypertension. A phase II randomized, double-blind, parallel-group, placebo-controlled, 22-week study of immediate-release (IR) ralinepag safety and efficacy met its primary endpoint, significantly reducing pulmonary vascular resistance (PVR) compared with placebo. This phase II open-label extension (OLE) study assessed long-term safety and tolerability of ralinepag.

Methods

Participants were eligible for the OLE if they completed the parent study or experienced a clinical worsening event while receiving placebo. Those previously receiving IR ralinepag remained on their current dose, and participants formerly administered placebo were titrated to

SUBMITTER: Barbera J 

PROVIDER: S-EPMC10879237 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature