At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 16 enrolled
Drug / intervention
current marketed FLOLAN (epoprostenol sodium) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.)
In Brief
A Phase 4 clinical trial evaluating current marketed FLOLAN (epoprostenol sodium) and new thermo stable formulation of epoprostenol sodium for Hypertension, Pulmonary. Completed, enrolled 16 participants across 8 sites in 3 countries.
Detailed Summary
The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesCanada, Netherlands, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartNov 2011
Primary CompletionMay 2012
Study CompletionNov 2012
TodayJul 2026
First PostedOct 31, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 16, 2012
Study CompletionNov 8, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.7 years ago
Interventions
current marketed FLOLAN (epoprostenol sodium)drug
continuous intravenous infusion
new thermo stable formulation of epoprostenol sodiumdrug
continuous intravenous infusion