Overview
Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
Status:
Completed
Completed
Trial end date:
2016-07-16
2016-07-16
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BayerTreatments:
Riociguat
Criteria
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