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NCT01436500 · ClinicalTrials.gov registry record · Phase 2
Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
A Phase 2 study, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT01436500: Completed Phase 2 study, sponsored by Cumberland Pharmaceuticals.
NCT01436500 is a Phase 2 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01436500, a Phase 2 study, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.
Primary Outcome
Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.
Interventions
- DRUG Placebo
- DRUG Ifetroban Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01436500 record still lists
NCT01436500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01436500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01436500 about?
NCT01436500 is a clinical study titled "Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients". A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.
What is the current status of trial NCT01436500?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2011-10. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01436500?
The interventions under investigation include: Placebo (DRUG), Ifetroban Injection (DRUG).
Who is sponsoring clinical trial NCT01436500?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01436500's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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