An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS

Bayer HealthCare AG0 sites36 target enrollmentJune 7, 2010

Overview

No summary available.

Registry

who.int

Start Date

June 7, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•18 to 75 years of age at Visit 1 (the lower age limit may be higher if legally requested in the participating countries).
•Male and female subjects with symptomatic PAH (Group I Dana Point Updated Clinical Classification 2008\), a 6\-min walking distance (6MWD) of more than 150 m, a pulmonary vascular resistance (PVR) \>300 dyn\*s\*cm\-5, and a mean pulmonary artery pressure (PAPmean) \= 25 mmHg either due to:
•\-Idiopathic PAH.
•\-Heritable PAH.
•\-Associated PAH due to connective tissue disease.
•\-Associated PAH due to congenital heart disease (ie atrial septal defect, ventricle septal defect, persistent ductus arteriosus), if subjects underwent surgical correction \>360 days before study inclusion.
•\-Associated PAH due to portal hypertension with liver cirrhosis. (Note: subjects with clinical relevant hepatic dysfunction are excluded; see exclusions related to disorders in organ function.)
•\-Associated PAH due to anorexigen or amphetamine use.
•Note: Other PAH subtypes of Dana Point Updated Clinical Classification Group I than the ones listed above, for example (eg) PAH associated with human immunodeficiency virus (HIV) infection, are excluded from the trial (see exclusion criteria).
•Note: With respect to the verification of the inclusion criteria, PAPmean and PVR are considered as calculated parameters.

•Subject’s participating in another clinical trial or who have done so within 30 days before Visit 1\.
•Previous assignment to treatment during this study.
•Pregnant women (ie positive serum beta\-human\-chorionic\-gonadotropin test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control (eg prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method, male partner sterilization) throughout the study.
•Subjects with a medical disorder, condition, or history of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator.
•Subjects with substance abuse (eg alcohol or drug abuse) within the previous 180 days before Visit 1\.
•Subjects with underlying medical disorders with an anticipated life expectancy below 2 years (eg active cancer disease with localized and/or metastasized tumor mass).
•Subjects with a history of severe allergies or multiple drug allergies.
•Subjects with hypersensitivity to the investigational drug or any of the excipients.
•Subjects unable to perform a valid 6MWD test, eg subjects with a severe peripheral artery occlusive disease.
•(Note: Subjects, who require walking aids, may be included if in the opinion of the investigator the walking distance is not impaired.)