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Safety and Efficacy Study of Acthar in Subjects With ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of H.P. Acthar® Gel (Acthar) in Subjects With Acute Respiratory Distress Syndrome (ARDS)

Clinical Trial Summary

This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome
Clinical Trial Details
NCT number NCT02113735
Study type Interventional
Source Mallinckrodt
Contact
Status Withdrawn
Phase Phase 2
Start date August 2014
Completion date August 2016
View Details
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