Phase
Condition
Pulmonary Arterial Hypertension
Circulation Disorders
Williams Syndrome
Treatment
Adempas (Riociguat, BAY63-2521)
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Besancon, 25030
FranceCompleted
Brest, F-29609
FranceCompleted
empty
Le Kremlin Bicetre Cedex, 94275
FranceSite Not Available
Le Kremlin Bicetre Cedex, 94275
FranceCompleted
Le Kremlin-bicetre, 94275
FranceCompleted
Lille Cedex, 59037
FranceCompleted
Rouen, 76031
FranceCompleted
Roma, Lazio 00161
ItalySite Not Available
Pavia, Lombardia 27100
ItalySite Not Available
Seoul, 138-736
Korea, Republic ofCompleted
Krakow, 31-202
PolandSite Not Available
Lodz, 91-347
PolandSite Not Available
Otwock, 05-400
PolandSite Not Available
Wroclaw, 51-124
PolandSite Not Available
Bangkok, 10330
ThailandSite Not Available
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