An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial (RIALTO)

STATUS

Recruiting
End date

Dec 28, 2025
participants needed

25
sponsor

Bayer

Updated on 24 October 2022

See if I qualify

pulmonary arterial hypertension

riociguat

adempas

Summary

To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

Details

Condition	Hypertension, Pulmonary
Treatment	Adempas (Riociguat, BAY63-2521)
Clinical Study Identifier	NCT02759419
Sponsor	Bayer
Last Modified on	24 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment
	Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug
Exclusion Criteria
	Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
	Pregnant women or breast-feeding women
	Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
	Concomitant participation in another clinical study with the study drug
	Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)

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An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial (RIALTO)