A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.

Last updated: October 2, 2025
Sponsor: Bayer
Overall Status: Completed

Phase

4

Condition

Circulation Disorders

Stress

Williams Syndrome

Treatment

Adempas (Riociguat, BAY63-2521)

Clinical Study ID

NCT02759419
18694
2016-000501-36
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating orhaving participated in the Bayer-sponsored studies 12935, 16719 or 18588, who havecompleted the main study phase and are still being treated with riociguat (eitherwhile still being on treatment with the respective study drug or by commercial meanswith Adempas) and who, in the opinion of the investigator, are expected to continueto have an overall positive benefit/risk from continuing treatment.

  • Women and men of reproductive potential must agree to use adequate contraceptionwhen sexually active. This applies for the time period between signing of theinformed consent form and 30 days after the last administration of study drug.

Exclusion

Exclusion Criteria:

  • Ongoing serious adverse event (SAE) from originating study that is assessed asrelated to riociguat

  • Pregnant women or breast-feeding women

  • Any contra-indication to Adempas treatment listed in the BAY63-2521 / RiociguatInvestigators's Brochure

  • Concomitant participation in another clinical study with the study drug

  • Patients with pulmonary hypertension associated with idiopathic interstitialpneumonia (PH-IIP)

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Adempas (Riociguat, BAY63-2521)
Phase: 4
Study Start date:
June 16, 2016
Estimated Completion Date:
September 15, 2025

Connect with a study center

  • empty

    Besancon, 25030
    France

    Site Not Available

  • Besancon, 25030
    France

    Completed

  • Besançon 3033123, 25030
    France

    Site Not Available

  • empty

    Brest, F-29609
    France

    Site Not Available

  • Brest, F-29609
    France

    Completed

  • Brest 3030300, F-29609
    France

    Site Not Available

  • empty

    Le Kremlin Bicetre Cedex, 94275
    France

    Site Not Available

  • Le Kremlin Bicetre Cedex, 94275
    France

    Completed

  • Le Kremlin-Bicêtre 3003737, 94275
    France

    Site Not Available

  • empty

    Le Kremlin-bicetre, 94275
    France

    Site Not Available

  • Lille 2998324, 59037
    France

    Site Not Available

  • empty

    Lille Cedex, 59037
    France

    Site Not Available

  • Lille Cedex, 59037
    France

    Completed

  • empty

    Rouen, 76031
    France

    Site Not Available

  • Rouen, 76031
    France

    Completed

  • Rouen 2982652, 76031
    France

    Site Not Available

  • empty

    Roma, Lazio 00161
    Italy

    Site Not Available

  • Roma, Lazio 00161
    Italy

    Site Not Available

  • empty

    Pavia, Lombardia 27100
    Italy

    Site Not Available

  • Pavia, Lombardia 27100
    Italy

    Site Not Available

  • empty

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • empty

    Krakow, 31-202
    Poland

    Site Not Available

  • Krakow, 31-202
    Poland

    Site Not Available

  • empty

    Lodz, 91-347
    Poland

    Site Not Available

  • Lodz, 91-347
    Poland

    Site Not Available

  • empty

    Otwock, 05-400
    Poland

    Site Not Available

  • Otwock, 05-400
    Poland

    Site Not Available

  • empty

    Wroclaw, 51-124
    Poland

    Site Not Available

  • Wroclaw, 51-124
    Poland

    Site Not Available

  • Seoul 1835848, Seoul Teugbyeolsi 05505
    South Korea

    Site Not Available

  • empty

    Bangkok, 10330
    Thailand

    Site Not Available

  • Bangkok, 10330
    Thailand

    Site Not Available

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