Conditions: Cardiovascular Disease
Keywords: Pulmonary Arterial Hypertension (PAH) safety FLOLAN New Thermostable Formulation dose adjustment reformulated diluents currently marketed diluent
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects will receive the existing FLOLAN treatment (i.e., FLOLAN injection prepared with the currently marketed diluent) for a run-in period of a maximum of 4 weeks, the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared with the reformulated diluent) for a 4-week treatment period and there will be a one-week follow-up visit.

Interventions: intervention 1: FLOLAN injection with currently marketed diluent intervention 2: FLOLAN injection with reformulated diluent
Intervention descriptions: intervention 1: FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the currently marketed diluent (epoprostenol sodium+ powder of hydrogen \[pH\] 10.2 - 10.8 diluent) for Injection. intervention 2: FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the reformulated diluent (epoprostenol sodium + pH 11.7 - 12.3 diluent) for Injection.

Protocol document: