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NCT01597635 · ClinicalTrials.gov registry record · Phase 2
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01597635 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 44 participants.
The verdict
NCT01597635, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects.
Interventions
- DRUG Placebo (saline)
- DRUG Dose 1 GSK2586881
- DRUG Dose 2 GSK2586881
- DRUG Dose 3 GSK2586881
- DRUG Dose 4 GSK2586881
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-09-01 |
| Est. Completion | 2014-10-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01597635
The ClinicalTrials.gov registry entry for NCT01597635 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo (saline) is the first listed.
NCT01597635 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01597635 about?
NCT01597635 is a clinical study titled "The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury". This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) ...
What is the current status of trial NCT01597635?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2012-09-01. Estimated completion is 2014-10-06.
What interventions are being tested in trial NCT01597635?
The interventions under investigation include: Placebo (saline) (DRUG), Dose 1 GSK2586881 (DRUG), Dose 2 GSK2586881 (DRUG), Dose 3 GSK2586881 (DRUG), Dose 4 GSK2586881 (DRUG).
Who is sponsoring clinical trial NCT01597635?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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