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NCT01343823 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
A Phase 2 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT01343823: Clinical Trial Phase 2 study, sponsored by Shire.
NCT01343823 is a Phase 2 study that was terminated before completion, run by Shire. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343823, a Phase 2 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study Summary
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
Primary Outcome
Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER. A responder was defined as a patient meeting all six discharge eligibility criteria as below: • Improvement of edema to "a little better" or "a lot bet
Interventions
- DRUG placebo
- DRUG ecallantide 60 mg
- DRUG ecallantide 30 mg
- DRUG ecallantide 10 mg
- DRUG placebo match for 30 mg ecallantide arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2011-06-01 |
| Est. Completion | 2012-06-01 |
| Phase | Phase 2 |
Why NCT01343823 stopped before completion
NCT01343823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT01343823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343823 about?
NCT01343823 is a clinical study titled "Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema". A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
What is the current status of trial NCT01343823?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2011-06-01. Estimated completion is 2012-06-01.
What interventions are being tested in trial NCT01343823?
The interventions under investigation include: placebo (DRUG), ecallantide 60 mg (DRUG), ecallantide 30 mg (DRUG), ecallantide 10 mg (DRUG), placebo match for 30 mg ecallantide arm (DRUG).
Who is sponsoring clinical trial NCT01343823?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343823's enrollment target sits among peer trials
79 884th of 2000 higher than 1,117 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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