At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
FE 202158 1.25 +3 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.
Infusion Proof-of-concept Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of FE 202158 in Patients With Vasodilatory Hypotension in Early Septic Shock
In Brief
A Phase 2 clinical trial evaluating FE 202158 1.25, FE 202158 2.5, and 2 other interventions for Septic Shock. Completed, enrolled 53 participants across 16 sites in 4 countries.
Detailed Summary
The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesBelgium, Canada, Denmark, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartNov 2009
Primary CompletionAug 2011
Study CompletionSep 2011
TodayJul 2026
First PostedOct 23, 2009
Enrollment StartNov 1, 2009
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.7 years ago
Interventions
FE 202158 1.25drug
FE 202158 at dose 1.25 ng/kg/min infused.
FE 202158 2.5drug
FE 202158 at dose 2.5 ng/kg/min infused.
FE 202158 3.75drug
FE 202158 at dose 3.75 ng/kg/min infused.
Placeboother
Isotonic saline infused.