Trial Condition(s):
Hypertension, Pulmonary
Measuring Outcomes In Patients with Pulmonary Arterial Hypertension not on Active Treatment (MOTION)
Bayer Identifier:
17407
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Troy, United States, 48085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Guaynabo, Puerto Rico, 00968 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pascagoula, United States, 39581 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site New Orleans, United States, 70112 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Mineola, United States, 10065 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Syracuse, United States, 13210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cincinnati, United States, 45267 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Miami Beach, United States, 33140 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cincinnati, United States, 45219 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site El Paso, United States, 79912 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Augusta, United States, 30912 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Miami, United States, 33143 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Lincoln, United States, 68506 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sioux Falls, United States, 57104 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Providence, United States, 02903-4900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Celebration, United States, 34747 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Orlando, United States, 32803 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Newark, United States, 07103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fort Wayne, United States, 46804 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Albany, United States, 12208 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Albuquerque, United States, 87131-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Marietta, United States, 30060 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site La Jolla, United States, 92093 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Moreno Valley, United States, 92553 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milwaukee, United States, 53226 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Boston, United States, 02111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Weston, United States, 33331 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pittsburgh, United States, 15212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Indianapolis, United States, 46260 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tucson, United States, 85724 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site San Juan Capistrano, United States, 92675 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Brooklyn, United States, 11229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Santa Barbara, United States, 93105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hartford, United States, 06102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cleveland, United States, 44106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Columbus, United States, 43221 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Temple, United States, 76508 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Stony Brook, United States, 11794-8172 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Omaha, United States, 68131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milwaukee, United States, 53215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Toledo, United States, 43614 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pomona, United States, 91767 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Atlanta, United States, 30342 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Portland, United States, 97225 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Liverpool, United States, 13088 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Austell, United States, 30106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site North Dartmouth, United States, 02747 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Change from baseline to Week 24 in the Living with Pulmonary Hypertension (LPH) questionnaire total scoreThe 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.Timeframe: Baseline to Week 24
Secondary Outcome
- Change from baseline to Weeks 4 and 16 in the LPH total scoreThe 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.Timeframe: 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.Timeframe: Week 16 to Week 24
- Change from baseline to Weeks 4, 16, and 24 in the LPH physical dimension scoreThe 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.Timeframe: 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.Timeframe: Week 16 to Week 24
- Change from baseline to Weeks 4, 16, and 24 in the LPH emotional dimension scoreThe 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.Timeframe: 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.Timeframe: 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 24For 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.Timeframe: 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 24For 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.Timeframe: 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 24For 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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 scoresThe 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.Timeframe: 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.Timeframe: 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) scoreSF-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.Timeframe: 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.Timeframe: Week 16 to Week 24
- Change from baseline to Weeks 4, 16, and 24 in the WHO functional classFunctional 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.Timeframe: 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.Timeframe: Week 16 to Week 24
- Change from baseline to Weeks 16 and 24 in the Modified Borg Dyspnea ScaleThe 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.Timeframe: 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).Timeframe: Week 16 to Week 24
- Change from baseline to Weeks 16 and 24 in the 6MWDSix-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.Timeframe: 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.Timeframe: Week 16 to Week 24
- Change from baseline to Weeks 4, 16, and 24 in the WLQ Percentage of productivity lossThe 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.Timeframe: 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.Timeframe: Week 16 to Week 24
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