Phase 4 N=75 Treatment

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

Hypertension, Pulmonary

Bottom Line

View on ClinicalTrials.gov: NCT02191137 ↗

Enrolled (actual)

Serious AEs

28.0%

Results posted

Oct 2017

Primary outcome: Primary: Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score — -10.99 Scores

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Riociguat (Adempas, BAY63-2521) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score	-10.99	—
SECONDARY Change From Baseline to Weeks 4 and 16 in the LPH Total Score	-7.65; -6.98	—
SECONDARY Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)	-1.66	—
SECONDARY Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score	-3.77; -3.97; -6.10	—
SECONDARY Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)	-0.86	—
SECONDARY Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score	-2.22; -1.44; -2.33	—
SECONDARY Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)	-0.11	—
SECONDARY Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24	38.9; 45.6; 47.0	—
SECONDARY Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24	45.8; 51.5; 60.0	—
SECONDARY Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24	31.9; 39.7; 33.3	—
SECONDARY Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)	24.1	—
SECONDARY Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)	29.8	—
SECONDARY Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)	17.2	—
SECONDARY Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores	4.17; 0.96; -8.59; -6.88; 0.56; 7.40	—
SECONDARY Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss	-1.07; 0.54; -0.53	—
SECONDARY 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)	-0.32; -1.56; 5.92; -4.78	—
SECONDARY Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)	0.19	—
SECONDARY 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	1.009; 0.036; 1.230; 1.955; 1.869; 2.883	—
SECONDARY Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)	1.383; 0.437	—
SECONDARY Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class	9.7; 87.5; 2.8; 0; 18.7; 66.7	—
SECONDARY Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)	1.8; 15.8; 70.2; 10.5; 1.8	—
SECONDARY Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale	-0.70; -0.91	—
SECONDARY Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)	-0.19	—
SECONDARY Change From Baseline to Weeks 16 and 24 in the 6MWD	2.362; -2.921	—
SECONDARY Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)	-7.932	—

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. 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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02191137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.