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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    25
  • sponsor
    Bayer
Updated on 10 September 2021
pulmonary arterial hypertension
riociguat
adempas

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.

Details
Condition Pulmonary Hypertension, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Memory Problems
Treatment Adempas (Riociguat, BAY63-2521)
Clinical Study IdentifierNCT02759419
SponsorBayer
Last Modified on10 September 2021

Eligibility

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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