Trial Condition(s):
Measuring Outcomes In Patients with Pulmonary Arterial Hypertension not on Active Treatment (MOTION)
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.
- 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
- 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
Locations | Status | ||
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Locations Investigative Site Troy, United States, 48085 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Guaynabo, Puerto Rico, 00968 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Pascagoula, United States, 39581 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Jacksonville, United States, 32209 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Iowa City, United States, 52242 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site New Orleans, United States, 70112 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Mineola, United States, 10065 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Syracuse, United States, 13210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Cincinnati, United States, 45267 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Miami Beach, United States, 33140 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Cincinnati, United States, 45219 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Houston, United States, 77030 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site El Paso, United States, 79912 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Augusta, United States, 30912 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Miami, United States, 33143 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Lincoln, United States, 68506 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Sioux Falls, United States, 57104 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Providence, United States, 02903-4900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Celebration, United States, 34747 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Orlando, United States, 32803 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Newark, United States, 07103 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Fort Wayne, United States, 46804 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Louisville, United States, 40202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Albany, United States, 12208 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Albuquerque, United States, 87131-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Marietta, United States, 30060 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site La Jolla, United States, 92093 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Moreno Valley, United States, 92553 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Milwaukee, United States, 53226 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Boston, United States, 02111 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Weston, United States, 33331 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Pittsburgh, United States, 15212 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Indianapolis, United States, 46260 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Tucson, United States, 85724 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site San Juan Capistrano, United States, 92675 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Brooklyn, United States, 11229 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Santa Barbara, United States, 93105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Hartford, United States, 06102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Cleveland, United States, 44106 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Columbus, United States, 43221 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Temple, United States, 76508 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Stony Brook, United States, 11794-8172 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site New Hyde Park, United States, 11040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Chicago, United States, 60612 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Omaha, United States, 68131 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Milwaukee, United States, 53215 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Cincinnati, United States, 45242 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Sacramento, United States, 95817 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Toledo, United States, 43614 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Pomona, United States, 91767 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Boston, United States, 02118 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Atlanta, United States, 30342 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Portland, United States, 97225 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Louisville, United States, 40202 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Liverpool, United States, 13088 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Austell, United States, 30106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Detroit, United States, 48202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site Philadelphia, United States, 19107 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Investigative Site North Dartmouth, United States, 02747 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients with Pulmonary Arterial Hypertension not on Active Treatment
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1