Status:
COMPLETED
Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02191137
Start Date
September 23 2014
End Date
July 16 2016
Last Update
October 13 2017
Active Locations (59)
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1
Tucson, Arizona, United States, 85724
2
La Jolla, California, United States, 92093
3
Moreno Valley, California, United States, 92553
4
Pomona, California, United States, 91767