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Efficacy & Safety of Resatorvid in Adults With Severe Sepsis

NCT00143611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2012-02-02

No results posted yet for this study

Summary

The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day all-cause mortality in subjects with severe sepsis.

Conditions

Interventions

DRUG

Resatorvid

Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.

DRUG

Resatorvid

Resatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.1 mg/kg/h (2.4 mg/kg/day), injection, subcutaneously over 96 hours.

DRUG

Placebo

Resatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Finland
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Puerto Rico
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00143611 on ClinicalTrials.gov