Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816)
Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator
Subjects who request the long-term extension administration of GSK1325760A, and agree to newly sign the informed consent form
You may not be if
Subjects who have been withdrawn from the Phase II/III study.
Female subjects who wish to become pregnant.
Treatment with other PAH medication is needed.
A worsening of 2 or more levels of the WHO Functional Classification (see Appendix 2.1) comparing with the baseline of Phase II/III study (Study No.AMB107816).
Worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during Phase II/III study (Study No.AMB107816).
Rapidly progressing cardiac, hepatic or renal failure during Phase II/III study (Study No.AMB107816).
Participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
Clareo Health | A Study to Evaluate GSK1325760A - a Long-Term Extension Study
