Clinical Trials & Pipeline

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Ongoing Trials

ROAR (RiOciguAt useRs registry)

To provide real-world evidence on the safety and effectiveness of riociguat as first-line and combination therapy in US adults with PAH

STUDY DESIGN

Prospective

Multicenter, observational

Treatment:

All treatment decisions, including the decision to treat with riociguat alone or in combination therapy, will be at the discretion of the treating physician and the patient

Visual representation of timeline for ROAR trial

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STUDY POPULATION

n=300 (fully enrolled, not accepting new patients)

Inclusion criteria:

Adults (aged ≥ 18 years)

Diagnosis of WHO Group 1 PAH per the 6th World Symposium on Pulmonary Hypertension (WSPH); Nice, France 2018 classification

Initiation of riociguat at enrollment or ≤ 90 days prior to enrollment with a documented titration regimen

Decision to initiate treatment with riociguat as per investigator’s routine treatment practice made before enrollment in the study

Signed informed consent

Exclusion criteria:

Previous treatment and discontinuation of riociguat therapy for any reason

Participation in a blinded clinical trial with interventions outside of routine clinical practice; participation in open-label extension trials is allowed

Life expectancy < 12 months

Contraindicated to receive riociguat per the FDA approved US label

Use of nitrates or NO donors in any form

Use of PDE5 inhibitors

PH associated with idiopathic interstitial pneumonias

Unable or unwilling to provide informed consent

ENDPOINTS

Primary outcomes:

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Change of 6-minute walk distance (6MWD) from baseline to Months 6 and 12

Change of BNP or NT-proBNP from baseline to Months 6 and 12

Change of clinical PAH scores from baseline to Months 6 and 12

Change of hemodynamic measurements from RHC from baseline to Months 6 and 12

Change of ECHO measurements from baseline to Months 6 and 12

Change of laboratory tests from baseline to Months 6 and 12

Change of NYHA/WHO PH functional class from baseline to Months 6 and 12

Secondary outcomes:

Change from baseline to Month 6 and change from baseline to Month 12 in Borg Dyspnea Index

Change from baseline to Month 6 and change from baseline to Month 12 in emPHasis-10

Persistence/discontinuation rates for riociguat

Reasons for discontinuation of riociguat

Real-world treatment patterns for riociguat for PAH

Demographic of patients treated with riociguat

Clinical characteristics of patients treated with riociguat

NCT04813926

References: 27. Sulica R, Mandras S, Miller C, White RJ, Kim NH, Bansilal S, et al. Rationale and design of the RiOciguAt UseRs (ROAR) registry. ATS 2022 International Conference, May 13–18, San Francisco, CA, USA. 28. Bayer. A study to learn about how well riociguat works, how safe it is and how it is used under real world conditions in patients in the United States who are receiving riociguat for high blood pressure in the arteries that carry blood from the heart to the lungs (Pulmonary Arterial Hypertension, PAH) (ROAR). https://clinicaltrials.gov/ct2/show/NCT04813926. 2022.

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Clinical Trials & Pipeline

Clinical Trials & Pipeline

Ongoing Trials

ROAR (RiOciguAt useRs registry)

STUDY DESIGN

STUDY POPULATION

Inclusion criteria:

Exclusion criteria:

ENDPOINTS

Primary outcomes:

Secondary outcomes:

Bayer's Clinical Trials Explorer

Bayer's Development Pipeline