Long-term treatment with Riociguat for patients with 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

This study is testing if long-term treatment with Riociguat can help people with pulmonary arterial hypertension who have already been part of earlier trials.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bayer (Industry-sponsored)
• Locations: 16 sites (Besancon and 15 other locations)
• Trial ID: NCT02759419 on ClinicalTrials.gov

What this trial studies

This study provides ongoing treatment with Riociguat (Adempas) for patients with symptomatic pulmonary arterial hypertension (PAH) who have previously participated in Bayer-sponsored trials. The aim is to continue therapy until the investigator determines that the patient is no longer benefiting from the treatment or until the drug becomes commercially available. Eligible patients must have completed the main study phase of prior trials and be assessed to have a positive benefit/risk ratio for continued treatment.

Who should consider this trial

Good fit: Ideal candidates are patients with PAH who have participated in specific Bayer-sponsored studies and are currently benefiting from Riociguat treatment.

Not a fit: Patients experiencing serious adverse events related to Riociguat or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help maintain effective treatment for patients with PAH, potentially improving their quality of life.

How similar studies have performed: Other studies involving Riociguat have shown positive outcomes, indicating that this approach has been successful in similar contexts.

Eligibility criteria

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)

Where this trial is running

Besancon and 15 other locations

• Besancon, France (Completed)
• Brest, France (Completed)
• Le Kremlin-bicetre, France (Completed)
• Lille Cedex, France (Completed)
• Rouen, France (Completed)
• Roma, Lazio, Italy (Withdrawn)
• Pavia, Lombardia, Italy (Withdrawn)
• Seoul, Seoul Teugbyeolsi, Korea, Republic of (Active_not_recruiting)
• Seoul, Korea, Republic of (Recruiting)
• Seoul, Korea, Republic of (Completed)
• Seoul, Korea, Republic of (Recruiting)
• Krakow, Poland (Withdrawn)
• Lodz, Poland (Withdrawn)
• Otwock, Poland (Withdrawn)
• Wroclaw, Poland (Withdrawn)
• Bangkok, Thailand (Withdrawn)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions Hypertension, Pulmonary