Projekt
Offene, nicht kontrollierte, multizentrische Phase IIIb Studie zur Beurteilung von Riociguat (BAY 63-2521) bei Patienten mit Chronisch Thromboembolischer Pulmonaler Hypertonie (CTEPH)
Abgebrochen · 2013 bis 2015
Brutsche Martin, Pellet Sarah, Finger Rebekka
Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Abgebrochen
Start
2013
Ende
2015
Finanzierungsart
Industrie
Studiendesign
The study will be conducted as an open-label, uncontrolled long-term
surveillance study to assess safety, tolerability, and clinical effects while providing early access of riociguat to patients with inoperable CTEPH, or recurrent or persisting PH after surgical treatment that are
not satisfactorily treated and cannot participate in any other CTEPH trial.
Kurzbeschreibung/Zielsetzung
Objective
1) To assess safety and tolerability, clinical effects of riociguat.
2) To provide access to riociguat for patients with in-operable chronic
thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated an d cannot participate in any other CTEPH trial.