check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

17407

ClinicalTrials.gov Identifier:

NCT02191137

EudraCT Number:

Not Available

EU CT Number:

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

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.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years
  • - 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

Trial summary

Enrollment Goal
75
Trial Dates
September 2014 - July 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Troy, 48085, United States
Completed
Guaynabo, 00968, Puerto Rico
Terminated
Pascagoula, 39581, United States
Completed
Aurora, 80045, United States
Completed
Jacksonville, 32209, United States
Terminated
Iowa City, 52242, United States
Completed
New Orleans, 70112, United States
Completed
Mineola, 10065, United States
Completed
Syracuse, 13210, United States
Completed
Cincinnati, 45267, United States
Terminated
Miami Beach, 33140, United States
Completed
Cincinnati, 45219, United States
Terminated
Houston, 77030, United States
Terminated
El Paso, 79912, United States
Terminated
Augusta, 30912, United States
Terminated
Miami, 33143, United States
Completed
Lincoln, 68506, United States
Terminated
Sioux Falls, 57104, United States
Completed
Providence, 02903-4900, United States
Completed
Celebration, 34747, United States
Completed
Orlando, 32803, United States
Terminated
Newark, 07103, United States
Completed
Fort Wayne, 46804, United States
Completed
Louisville, 40202, United States
Completed
Albany, 12208, United States
Completed
Albuquerque, 87131-0001, United States
Completed
Marietta, 30060, United States
Terminated
La Jolla, 92093, United States
Terminated
Moreno Valley, 92553, United States
Terminated
Milwaukee, 53226, United States
Terminated
Boston, 02111, United States
Completed
Weston, 33331, United States
Completed
Pittsburgh, 15212, United States
Completed
Indianapolis, 46260, United States
Completed
Tucson, 85724, United States
Terminated
San Juan Capistrano, 92675, United States
Terminated
Brooklyn, 11229, United States
Completed
Santa Barbara, 93105, United States
Completed
Hartford, 06102, United States
Completed
Cleveland, 44106, United States
Completed
Columbus, 43221, United States
Terminated
Temple, 76508, United States
Completed
Stony Brook, 11794-8172, United States
Completed
New Hyde Park, 11040, United States
Completed
Chicago, 60612, United States
Terminated
Omaha, 68131, United States
Completed
Milwaukee, 53215, United States
Completed
Cincinnati, 45242, United States
Completed
Sacramento, 95817, United States
Terminated
Toledo, 43614, United States
Completed
Pomona, 91767, United States
Terminated
Boston, 02118, United States
Terminated
Atlanta, 30342, United States
Completed
Portland, 97225, United States
Terminated
Louisville, 40202, United States
Completed
Liverpool, 13088, United States
Terminated
Austell, 30106, United States
Completed
Detroit, 48202, United States
Completed
Philadelphia, 19107, United States
Terminated
North Dartmouth, 02747, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Baseline to Week 24

Secondary Outcome

  • Change from baseline to Weeks 4 and 16 in the LPH 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. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4 and Week 16
  • Change from Week 16 to Week 24 in the LPH total score (Completers analysis set only)
    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.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 4, 16, and 24 in the LPH physical dimension score
    The LPH derived from the Minnesota Living 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 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Weeks 4, 16, and 24
  • Change from Week 16 to Week 24 in the LPH physical dimension score (Completers analysis set only)
    The LPH derived from the Minnesota Living 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 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 4, 16, and 24 in the LPH emotional dimension score
    The LPH derived from the Minnesota Living 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 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Change from Week 16 to Week 24 in the LPH emotional dimension score (Completers analysis set only)
    The LPH derived from the Minnesota Living 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 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Percentage of patients with a minimal clinically significant important difference (MCID) from baseline in LPH total score at Weeks 4, 16, and 24
    For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Percentage of patients with an MCID from baseline in LPH physical dimension score at Weeks 4, 16, and 24
    For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Percentage of patients with an MCID from baseline in LPH emotional dimension score at Weeks 4, 16, and 24
    For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Percentage of patients with an MCID from Week 16 in LPH total score at Week 24 (Completers analysis set only)
    For LPH total score, the MCID was an 11-point decrease.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Percentage of patients with an MCID from Week 16 in physical dimension score at Week 24 (Completers analysis set only)
    For the physical and emotional dimension scores, the MCID was a 4-point decrease.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Percentage of patients with an MCID from Week 16 in emotional dimension score at Week 24 (Completers analysis set only)
    For the physical and emotional dimension scores, the MCID was a 4-point decrease.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands scores
    The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Change from Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands scores (Completers analysis set only)
    The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) physical component summary (PCS) score and mental component summary (MCS) score
    SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient’s point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Change from Week 16 to Week 24 in the SF-12 PCS score and MCS score (Completers analysis set only)
    SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient’s point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 4, 16, and 24 in the WHO functional class
    Functional class was determined by the WHO classification: I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope. II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope. III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope. IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Change from Week 16 to Week 24 in the WHO functional class (Completers analysis set only)
    Functional class was determined by the WHO classification: I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope. II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope. III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope. IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale
    The Modified Borg Dyspnea Scale assessed the intensity of the patient’s dyspnea from 0 (best) to 10 (worst). In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers analysis set only)
    The Modified Borg Dyspnea Scale assessed the intensity of the patient’s dyspnea from 0 (best) to 10 (worst).
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 16 and 24 in the 6MWD
    Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from Week 16 to Week 24 in the 6MWD (Completers analysis set only)
    Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured.
    date_rangeTime Frame:
    Week 16 to Week 24
  • Change from baseline to Weeks 4, 16, and 24 in the WLQ Percentage of productivity loss
    The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.
    date_rangeTime Frame:
    Baseline to Week 4, Week 16 and Week 24
  • Change from Week 16 to Week 24 in the WLQ Percentage of Productivity loss (Completers analysis set only)
    The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.
    date_rangeTime Frame:
    Week 16 to Week 24

Trial design

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

Additional Information

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