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Hypertension, PulmonaryPhase 4NCT02191137

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

A Phase 4 study testing Riociguat (Adempas, BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension, Pulmonary
What is being tested?
Riociguat (Adempas, BAY63-2521)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
59 sitesin 2 countries
Study dates
23 Sep 2014to 16 Jul 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States58 sites
  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87131-0001

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austell, Georgia, 30106

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Brooklyn, New York, 11229

  • Study site

    Celebration, Florida, 34747

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Columbus, Ohio, 43221

  • Study site

    Detroit, Michigan, 48202

  • Study site

    El Paso, Texas, 79912

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Hartford, Connecticut, 06102

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    La Jolla, California, 92093

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    Liverpool, New York, 13088

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33143

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Mineola, New York, 10065

  • Study site

    Moreno Valley, California, 92553

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    Newark, New Jersey, 07103

  • Study site

    North Dartmouth, Massachusetts, 02747

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orlando, Florida, 32803

  • Study site

    Pascagoula, Mississippi, 39581

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Pomona, California, 91767

  • Study site

    Portland, Oregon, 97225

  • Study site

    Providence, Rhode Island, 02903-4900

  • Study site

    Sacramento, California, 95817

  • Study site

    San Juan Capistrano, California, 92675

  • Study site

    Santa Barbara, California, 93105

  • Study site

    Sioux Falls, South Dakota, 57104

  • Study site

    Stony Brook, New York, 11794-8172

  • Study site

    Syracuse, New York, 13210

  • Study site

    Temple, Texas, 76508

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Troy, Michigan, 48085

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Weston, Florida, 33331

Other trials in United States

Puerto Rico1 site
  • Study site

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

Official title: A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment

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.

Being tested
Riociguat (Adempas, BAY63-2521)
Keywords
Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire
Medical subject headings
Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02191137
Study groupRoleWhat they receive
Riociguat 0.5mg to 2.5 mgExperimentalSingle arm, open label
Receives: Drug: Riociguat (Adempas, BAY63-2521)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 24

Secondary outcomes (24)
  1. 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.

    Measured: Baseline to Week 4 and Week 16

  2. 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.

    Measured: Week 16 to Week 24

  3. 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.

    Measured: Baseline to Weeks 4, 16, and 24

  4. 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.

    Measured: Week 16 to Week 24

  5. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  6. 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.

    Measured: Week 16 to Week 24

  7. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  8. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  9. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  10. 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.

    Measured: Week 16 to Week 24

  11. 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.

    Measured: Week 16 to Week 24

  12. 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.

    Measured: Week 16 to Week 24

  13. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  14. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  15. 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.

    Measured: Week 16 to Week 24

  16. 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.

    Measured: Week 16 to Week 24

  17. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  18. 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.

    Measured: Week 16 to Week 24

  19. 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.

    Measured: Baseline to Week 4, Week 16 and Week 24

  20. 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.

    Measured: Week 16 to Week 24

  21. 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.

    Measured: Week 16 to Week 24

  22. 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).

    Measured: Week 16 to Week 24

  23. 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.

    Measured: Week 16 to Week 24

  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.

    Measured: Week 16 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2014 (estimated)
  2. Study start23 Sep 2014
  3. Primary completion16 Jul 2016
  4. Study completion16 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02191137
Sponsor's protocol ID
17407
Status last verified
Sep 2017
First submitted
27 Jun 2014
Last updated
13 Oct 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 27890471

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Riociguat (Adempas, BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02191137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.

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