A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment

Motion [NCT02191137]

Description: The MOTION study is a prospective, Phase IV study, enrolling 100 patients with Pulmonary Arterial Hypertension (PAH). The study designed to further explore patient-reported outcomes in PAH subjects who are not on active treatment and living in the United States. In addition, the study will be exploring the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH

Drug: Riociguat (Adempas,BAY63-2521)

Primary Investigator: Engel

Drug/Device Information
Phase IV, prospective, single-Arm, open-label study to measure outcomes in patients with Pulmonary Arterial Hypertension not on active treatment
Riociguat (BAY 63-2521) is a direct stimulator of soluble guanylate cyclase (sGC)
Bayer HealthCare
Major Inclusion and Exclusion
Age 18 to 80 with symptomatic PAH (WHO Group 1)
PVR > 300, mean PAP ≥ 25, and PCWP ≤ 15
Not treated with PAH-specific pulmonary vasodilator medications within 14 days of screening
6MWD between 150 meters and 450 meters
No FEV1 < 60% or TLC <50%
No history of smoking tobacco within the last 3 months
No GFR < 30 mL/min
No left heart failure