Trial Condition(s):

Hypertension, Pulmonary

Measuring Outcomes In Patients with Pulmonary Arterial Hypertension not on Active Treatment (MOTION)

Bayer Identifier:

17407

ClinicalTrials.gov Identifier:

NCT02191137

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
75
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Troy, United States, 48085

Status
Terminated
 
Locations

Investigative Site

Guaynabo, Puerto Rico, 00968

Status
Completed
 
Locations

Investigative Site

Pascagoula, United States, 39581

Status
Terminated
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Jacksonville, United States, 32209

Status
Completed
 
Locations

Investigative Site

Iowa City, United States, 52242

Status
Terminated
 
Locations

Investigative Site

New Orleans, United States, 70112

Status
Completed
 
Locations

Investigative Site

Mineola, United States, 10065

Status
Completed
 
Locations

Investigative Site

Syracuse, United States, 13210

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45267

Status
Completed
 
Locations

Investigative Site

Miami Beach, United States, 33140

Status
Terminated
 
Locations

Investigative Site

Cincinnati, United States, 45219

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Terminated
 
Locations

Investigative Site

El Paso, United States, 79912

Status
Terminated
 
Locations

Investigative Site

Augusta, United States, 30912

Status
Terminated
 
Locations

Investigative Site

Miami, United States, 33143

Status
Terminated
 
Locations

Investigative Site

Lincoln, United States, 68506

Status
Completed
 
Locations

Investigative Site

Sioux Falls, United States, 57104

Status
Terminated
 
Locations

Investigative Site

Providence, United States, 02903-4900

Status
Completed
 
Locations

Investigative Site

Celebration, United States, 34747

Status
Completed
 
Locations

Investigative Site

Orlando, United States, 32803

Status
Completed
 
Locations

Investigative Site

Newark, United States, 07103

Status
Terminated
 
Locations

Investigative Site

Fort Wayne, United States, 46804

Status
Completed
 
Locations

Investigative Site

Louisville, United States, 40202

Status
Completed
 
Locations

Investigative Site

Albany, United States, 12208

Status
Completed
 
Locations

Investigative Site

Albuquerque, United States, 87131-0001

Status
Completed
 
Locations

Investigative Site

Marietta, United States, 30060

Status
Completed
 
Locations

Investigative Site

La Jolla, United States, 92093

Status
Terminated
 
Locations

Investigative Site

Moreno Valley, United States, 92553

Status
Terminated
 
Locations

Investigative Site

Milwaukee, United States, 53226

Status
Terminated
 
Locations

Investigative Site

Boston, United States, 02111

Status
Terminated
 
Locations

Investigative Site

Weston, United States, 33331

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15212

Status
Completed
 
Locations

Investigative Site

Indianapolis, United States, 46260

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85724

Status
Completed
 
Locations

Investigative Site

San Juan Capistrano, United States, 92675

Status
Terminated
 
Locations

Investigative Site

Brooklyn, United States, 11229

Status
Terminated
 
Locations

Investigative Site

Santa Barbara, United States, 93105

Status
Completed
 
Locations

Investigative Site

Hartford, United States, 06102

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44106

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43221

Status
Completed
 
Locations

Investigative Site

Temple, United States, 76508

Status
Terminated
 
Locations

Investigative Site

Stony Brook, United States, 11794-8172

Status
Completed
 
Locations

Investigative Site

New Hyde Park, United States, 11040

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60612

Status
Completed
 
Locations

Investigative Site

Omaha, United States, 68131

Status
Terminated
 
Locations

Investigative Site

Milwaukee, United States, 53215

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45242

Status
Completed
 
Locations

Investigative Site

Sacramento, United States, 95817

Status
Completed
 
Locations

Investigative Site

Toledo, United States, 43614

Status
Terminated
 
Locations

Investigative Site

Pomona, United States, 91767

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Terminated
 
Locations

Investigative Site

Atlanta, United States, 30342

Status
Terminated
 
Locations

Investigative Site

Portland, United States, 97225

Status
Completed
 
Locations

Investigative Site

Louisville, United States, 40202

Status
Terminated
 
Locations

Investigative Site

Liverpool, United States, 13088

Status
Completed
 
Locations

Investigative Site

Austell, United States, 30106

Status
Terminated
 
Locations

Investigative Site

Detroit, United States, 48202

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19107

Status
Completed
 
Locations

Investigative Site

North Dartmouth, United States, 02747

Status
Terminated
 

Trial Design