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

NCT01000649 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-09-25

Study results available
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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.

Conditions

  • Septic Shock

Interventions

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.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States
  • Belgium
  • Canada
  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000649 on ClinicalTrials.gov