Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02705807
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2016-02-25
Brief Title:
Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Label Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN in Japanese Subjects With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie FLOLAN injection prepared with the reformulated diluent when switched from the existing FLOLAN injection treatment ie 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 ie FLOLAN injection prepared with the currently marketed diluent a 4-week treatment period with the thermostable formulation of FLOLAN injection ie 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None