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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02191137
• Date of registration: 27/06/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
• Scientific title: A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment
• Date of first enrolment: September 23, 2014
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02191137
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: Riociguat (Adempas, BAY63-2521)

Primary Outcome(s)

Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score [Time Frame: Baseline to Week 24]

Secondary Outcome(s)

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 Modified Borg Dyspnea Scale (Completers Analysis Set Only) [Time Frame: Week 16 to 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 LPH Physical Dimension Score (Completers Analysis Set Only) [Time Frame: Week 16 to 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 16 and 24 in the 6MWD [Time Frame: Week 16 to Week 24]

Change From Baseline to Weeks 4 and 16 in the LPH Total Score [Time Frame: Baseline to Week 4 and Week 16]

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]

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 Baseline to Weeks 4, 16, and 24 in the WHO Functional Class [Time Frame: Baseline to Week 4, Week 16 and 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]

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 WLQ Percentage of Productivity Loss (Completers Analysis Set Only) [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]

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]

Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale [Time Frame: Week 16 to 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]

Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only) [Time Frame: Week 16 to 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]

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 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 Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only) [Time Frame: Week 16 to Week 24]

Change From Week 16 to Week 24 in the LPH Total Score (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]

Secondary ID(s)

17407

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/10/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02191137