NCT02759419CompletedPhase 4
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.
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
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 29 Apr 2016
- Start date
- 16 Jun 2016
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- Bayer
- NCT number
- NCT02759419
- EudraCT number
- 2016-000501-36
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 18
- From 16 Jun 2016 to the primary completion date, 15 Sept 2025
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant participation in another clinical study with the study drug
Other illness
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| - Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| - Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| - Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| - Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.