Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (Adempas, BAY63-2521)
Intervention description: 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.
Intervention MeSH terms: Riociguat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire

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.
    

Eligibility criteria:

        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