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.
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
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.
- Conditions
- Hypertension, Pulmonary
- 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 group | Role | What they receive |
|---|---|---|
| Riociguat 0.5mg to 2.5 mg | Experimental | Single 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Jul 2014 (estimated)
- Study start23 Sep 2014
- Primary completion16 Jul 2016
- Study completion16 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment
- ClinicalTrials.gov ID
- NCT02191137
- Acronym / sponsor ID
- 17407
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 16 Jul 2016 (actual)
- Study completion
- 16 Jul 2016 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Riociguat 0.5mg to 2.5 mg | Experimental | Drug: Riociguat (Adempas, BAY63-2521)Single arm, open label |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riociguat (Adempas, BAY63-2521)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. | Drug | Riociguat 0.5mg to 2.5 mg |
Primary outcome
Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score
Time frame: Baseline to Week 24
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.
24 secondary outcomes
Change From Baseline to Weeks 4 and 16 in the LPH Total Score
Time frame: Baseline to Week 4 and Week 16
Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)
Time frame: Week 16 to Week 24
Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score
Time 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)
Time frame: Week 16 to Week 24
Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score
Time 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)
Time 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
Time 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
Time 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
Time 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)
Time 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)
Time 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)
Time 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
Time frame: Baseline to Week 4, Week 16 and Week 24
Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss
Time 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)
Time frame: Week 16 to Week 24
Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)
Time 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
Time 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)
Time frame: Week 16 to Week 24
Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class
Time 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)
Time frame: Week 16 to Week 24
Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale
Time frame: Week 16 to Week 24
Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)
Time frame: Week 16 to Week 24
Change From Baseline to Weeks 16 and 24 in the 6MWD
Time frame: Week 16 to Week 24
Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)
Time frame: Week 16 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27890471Mathai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
59 sites in 2 countries: see every site and its status.
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.