Blood pressure drug riociguat tested for Long-Term use in rare lung condition
NCT ID NCT02759419
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the long-term safety of the drug riociguat (Adempas) in adults with pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs. It included 18 people who had already taken riociguat in earlier Bayer studies. The main goal was to track side effects and see if continuing the drug was safe over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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18 people
The number who actually took part.
- Started
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Jun 2016
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Study site
Besançon, 25030, France
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Study site
Brest, F-29609, France
-
Study site
Le Kremlin-Bicêtre, 94275, France
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Study site
Lille, 59037, France
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Study site
Rouen, 76031, France
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Study site
Seoul, Seoul Teugbyeolsi, 03722, South Korea
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Study site
Seoul, Seoul Teugbyeolsi, 05505, South Korea
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Study site
Seoul, Seoul Teugbyeolsi, 3080, South Korea
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Study site
Seoul, 06351, South Korea
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