Trials / Withdrawn
WithdrawnNCT02113735
Safety and Efficacy Study of Acthar in Subjects With ARDS
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)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Mallinckrodt · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | H.P. Acthar® Gel (repository corticotropin injection) | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2014-04-15
- Last updated
- 2017-09-27
Source: ClinicalTrials.gov record NCT02113735. Inclusion in this directory is not an endorsement.