Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
This study is a Phase IV, open-label, single-arm study to assess the safety and the necessity
of dose adjustment after switching to FLOLAN injection prepared with the reformulated diluent
in Japanese patients with PAH who are receiving higher doses of FLOLAN injection than in
other countries. The objective is to evaluate the safety and tolerability of the thermostable
formulation of FLOLAN injection (that is [i.e.], FLOLAN injection prepared with the
reformulated diluent) when switched from the existing FLOLAN injection treatment (i.e.,
FLOLAN injection prepared with the currently marketed diluent). The study will include a
screening visit, a run-in period of a maximum of 4 weeks with the existing FLOLAN treatment
(i.e., FLOLAN injection prepared with the currently marketed diluent), a 4-week treatment
period with the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared
with the reformulated diluent) and a one-week follow-up visit. Adequate number of subjects
will be enrolled in the study in order to have 10 subjects to complete assessments at 4
weeks, including at least 5 subjects as a subset of subjects who consent to undergo right
heart catheterisation (RHC) over 24-hour and at Week 4. FLOLAN is a registered trademark of
the GlaxoSmithKline [GSK] group of companies.