Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
NCT ID: NCT02191137
Last Updated: 2017-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2014-09-23
2016-07-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Riociguat 0.5mg to 2.5 mg
Single arm, open label
Riociguat (Adempas, BAY63-2521)
Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
Interventions
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Riociguat (Adempas, BAY63-2521)
Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Tucson, Arizona, United States
La Jolla, California, United States
Moreno Valley, California, United States
Pomona, California, United States
Sacramento, California, United States
San Juan Capistrano, California, United States
Santa Barbara, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
Celebration, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Austell, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
North Dartmouth, Massachusetts, United States
Detroit, Michigan, United States
Troy, Michigan, United States
Pascagoula, Mississippi, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Liverpool, New York, United States
Mineola, New York, United States
New Hyde Park, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Sioux Falls, South Dakota, United States
El Paso, Texas, United States
Houston, Texas, United States
Temple, Texas, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Guaynabo, , Puerto Rico
Countries
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References
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Mathai SC, Minai O, Sullivan SD, Lerner D, Levine D. Rationale and study design of MOTION: A phase 4, prospective, single-arm, open-label study to measure outcomes in patients with pulmonary arterial hypertension not on active treatment. Respir Med. 2017 Jan;122 Suppl 1:S23-S27. doi: 10.1016/j.rmed.2016.11.002. Epub 2016 Nov 2.
Other Identifiers
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17407
Identifier Type: -
Identifier Source: org_study_id