Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)

Bayer

Status and phase

Completed

Phase 4

Conditions

Hypertension, Pulmonary

Treatments

Drug: Riociguat (Adempas, BAY63-2521)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191137

17407

Details and patient eligibility

About

The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored 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.

Enrollment

75 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients, 18 to 80 years of age at Visit 0
Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance
Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5, mean pulmonary artery pressure (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)
PAH of the following types:

Idiopathic (IPAH) Familial (FPAH)

Associated with PAH (APAH) due to:

Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis

Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)
6MWD between 150 meters and 450 meters

Exclusion criteria

Patients who are pregnant
Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)
Non-WHO group 1 Pulmonary Hypertension
Severe restrictive lung disease
History of uncontrolled high blood pressure or hypotension
A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study
Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization