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NCT01000649 · ClinicalTrials.gov registry record · Phase 2
Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
A Phase 2 study, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT01000649: Completed Phase 2 study, sponsored by Ferring Pharmaceuticals.
NCT01000649 is a Phase 2 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01000649, a Phase 2 study, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.
Primary Outcome
Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method. The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Interventions
- OTHER Placebo
- DRUG FE 202158 1.25
- DRUG FE 202158 2.5
- DRUG FE 202158 3.75
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
What the finished NCT01000649 record still lists
NCT01000649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01000649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01000649 about?
NCT01000649 is a clinical study titled "Effects of the V1a Agonist FE 202158 in Patients With Septic Shock". The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.
What is the current status of trial NCT01000649?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2009-11. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01000649?
The interventions under investigation include: Placebo (OTHER), FE 202158 1.25 (DRUG), FE 202158 2.5 (DRUG), FE 202158 3.75 (DRUG).
Who is sponsoring clinical trial NCT01000649?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01000649's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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