Trial Condition(s):

Hypertension, Pulmonary

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

Bayer Identifier:

17407

ClinicalTrials.gov Identifier:

NCT02191137

EudraCT Number:

Not Available

Study Completed

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

September2014

July2016

Phase

Could I receive a placebo?

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Investigative Site Troy, United States, 48085	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Guaynabo, Puerto Rico, 00968	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Pascagoula, United States, 39581	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Aurora, United States, 80045	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Jacksonville, United States, 32209	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Iowa City, United States, 52242	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site New Orleans, United States, 70112	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Mineola, United States, 10065	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Syracuse, United States, 13210	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Cincinnati, United States, 45267	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Miami Beach, United States, 33140	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Cincinnati, United States, 45219	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Houston, United States, 77030	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site El Paso, United States, 79912	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Augusta, United States, 30912	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Miami, United States, 33143	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Lincoln, United States, 68506	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Sioux Falls, United States, 57104	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Providence, United States, 02903-4900	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Celebration, United States, 34747	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Orlando, United States, 32803	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Newark, United States, 07103	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Fort Wayne, United States, 46804	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Louisville, United States, 40202	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Albany, United States, 12208	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Albuquerque, United States, 87131-0001	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Marietta, United States, 30060	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site La Jolla, United States, 92093	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Moreno Valley, United States, 92553	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Milwaukee, United States, 53226	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Boston, United States, 02111	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Weston, United States, 33331	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Pittsburgh, United States, 15212	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Indianapolis, United States, 46260	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Tucson, United States, 85724	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site San Juan Capistrano, United States, 92675	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Brooklyn, United States, 11229	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Santa Barbara, United States, 93105	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Hartford, United States, 06102	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Cleveland, United States, 44106	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Columbus, United States, 43221	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Temple, United States, 76508	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Stony Brook, United States, 11794-8172	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site New Hyde Park, United States, 11040	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Chicago, United States, 60612	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Omaha, United States, 68131	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Milwaukee, United States, 53215	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Cincinnati, United States, 45242	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Sacramento, United States, 95817	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Toledo, United States, 43614	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Pomona, United States, 91767	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Boston, United States, 02118	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Atlanta, United States, 30342	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Portland, United States, 97225	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Louisville, United States, 40202	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Liverpool, United States, 13088	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Austell, United States, 30106	Status Terminated	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Detroit, United States, 48202	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site Philadelphia, United States, 19107	Status Completed	Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937
Locations Investigative Site North Dartmouth, United States, 02747	Status Terminated	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:

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.
Timeframe: 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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) 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.
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 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.
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 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.
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 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.
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 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.
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

Hypertension, Pulmonary

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

80 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information