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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01597635 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Vital sign included heart rate. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.
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 |
What the finished NCT01597635 record still lists
NCT01597635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo (saline) is the first listed.
NCT01597635 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01597635's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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