Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
237
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Time frame: From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years
Number of Participants With Death
Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.
Time frame: From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to Termination visit, up to 10 years
Change From Baseline of Hemoglobin in Hematology and Coagulation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
La Jolla, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Iowa City, Iowa, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Corrientes, Argentina
Unnamed facility
Prahran, Victoria, Australia
...and 63 more locations
Hemoglobin is standard Hematology and coagulation parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to Termination visit, up to 10 years
Change From Baseline of Urate in Clinical Chemistry
Urate is standard clinical chemistry parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Time frame: From baseline to Termination visit, up to 10 years