Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)

NCT02191137 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17407
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 59

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 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.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score

  The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.

  Baseline to Week 24

Secondary Outcomes (24)

• Change From Baseline to Weeks 4 and 16 in the LPH Total Score

  Baseline to Week 4 and Week 16

• Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)

  Week 16 to Week 24

• Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score

  Baseline to Weeks 4, 16, and 24

• Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)

  Week 16 to Week 24

• Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score

  Baseline to Week 4, Week 16 and Week 24

Study Arms (1)

Riociguat 0.5mg to 2.5 mg

EXPERIMENTAL

Single arm, open label

Drug: Riociguat (Adempas, BAY63-2521)

Interventions

Riociguat (Adempas, BAY63-2521) DRUG

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.

Riociguat 0.5mg to 2.5 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• MWD between 150 meters and 450 meters

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (59)

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Tucson, Arizona, 85724, United States

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La Jolla, California, 92093, United States

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Moreno Valley, California, 92553, United States

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Pomona, California, 91767, United States

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Sacramento, California, 95817, United States

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San Juan Capistrano, California, 92675, United States

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Santa Barbara, California, 93105, United States

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Aurora, Colorado, 80045, United States

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Hartford, Connecticut, 06102, United States

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Celebration, Florida, 34747, United States

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Jacksonville, Florida, 32209, United States

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Miami, Florida, 33143, United States

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Miami Beach, Florida, 33140, United States

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Orlando, Florida, 32803, United States

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Weston, Florida, 33331, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30912, United States

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Austell, Georgia, 30106, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60612, United States

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Fort Wayne, Indiana, 46804, United States

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Indianapolis, Indiana, 46260, United States

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Iowa City, Iowa, 52242, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70112, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02118, United States

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North Dartmouth, Massachusetts, 02747, United States

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Detroit, Michigan, 48202, United States

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Troy, Michigan, 48085, United States

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Pascagoula, Mississippi, 39581, United States

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Lincoln, Nebraska, 68506, United States

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Omaha, Nebraska, 68131, United States

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Newark, New Jersey, 07103, United States

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Albuquerque, New Mexico, 87131-0001, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11229, United States

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Liverpool, New York, 13088, United States

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Mineola, New York, 10065, United States

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New Hyde Park, New York, 11040, United States

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Stony Brook, New York, 11794-8172, United States

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Syracuse, New York, 13210, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43221, United States

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Toledo, Ohio, 43614, United States

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Portland, Oregon, 97225, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Providence, Rhode Island, 02903-4900, United States

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Sioux Falls, South Dakota, 57104, United States

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El Paso, Texas, 79912, United States

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Houston, Texas, 77030, United States

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Temple, Texas, 76508, United States

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Milwaukee, Wisconsin, 53215, United States

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Milwaukee, Wisconsin, 53226, United States

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Guaynabo, 00968, Puerto Rico

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Related Publications (1)

• 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.

  PMID: 27890471 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 16, 2014
• Study Start: September 23, 2014
• Primary Completion: July 16, 2016
• Study Completion: July 16, 2016
• Last Updated: October 13, 2017
• Results First Posted: October 13, 2017

Record last verified: 2017-09

Locations

PR (1); US (58)