NCT01000649

Effects of the V1a Agonist FE 202158 in Patients With Septic Shock

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multi-centre, double-blind, randomized, placebo-controlled, parallel group trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of FE 202158 (using three ascending doses) in patients with vasodilatory hypotension in early septic shock, when given as continuous infusion for up to 7 days. The trial comprised of three treatment arms where FE 202158 was administered in 1.25 ng, 2.5 ng and 3.75 ng dose, respectively. A placebo arm was also included in the trial where patients received isotonic saline. Efficacy of FE 202158 was determined by evaluating its ability to maintain mean arterial pressure (MAP) \>60 mmHg and its modulating effect on inflammatory markers. Effects of FE 202158 on other variables like vital signs, morbidity, mortality and pulmonary function were also determined.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	FE 202158 1.25	FE 202158 at dose 1.25 ng/kg/min infused.
DRUG	FE 202158 2.5	FE 202158 at dose 2.5 ng/kg/min infused.
DRUG	FE 202158 3.75	FE 202158 at dose 3.75 ng/kg/min infused.
OTHER	Placebo	Isotonic saline infused.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2009-10-23
• Last updated: 2017-09-25
• Results posted: 2017-06-02

Locations

16 sites across 4 countries: United States, Belgium, Canada, Denmark