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)

  • End date
    Dec 28, 2025
  • participants needed
  • sponsor
Updated on 24 October 2022
pulmonary arterial hypertension


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.

Condition Hypertension, Pulmonary
Treatment Adempas (Riociguat, BAY63-2521)
Clinical Study IdentifierNCT02759419
Last Modified on24 October 2022


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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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