- Subjects (≥18 years old) receiving oral Revatio 20 mg TID for PAH within the approved
indication (EU Summary of Product Characteristics) for a minimum of 1-month and who,
in the investigator's opinion, have demonstrated good tolerability. Subjects with PAH
who are nil by mouth for any reason (eg, elective surgery or medical procedure, TPN
feeding, gastrointestinal disturbance etc) may also be included in the study provided
they are haemodynamically stable (see Inclusion Criterion 4) and the 6 hour period of
blood pressure and pulse monitoring in the study does not interfere with any planned
medical or surgical intervention.
- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan and
study tests and procedures.
- Any subject receiving Revatio outside ('off-label') of the current Summary of Product
Characteristics (SmPC).
- Other severe acute or chronic medical or psychiatric condition that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this study.
- Introduction of potent CYP 3A4 inhibitors (eg, ketoconazole, itraconazole and
ritonavir) within the previous 1 month of screening.