Trial · NCT01343823
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
NCT01343823, Phase 2, Terminated, Shire; results first posted 2013-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema. Trials, record NCT01343823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01343823
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
- NCT number
- NCT01343823
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Shire
- Conditions
- ACE Inhibitor Induced Angioedema
- Interventions
- ecallantide 60 mg, ecallantide 30 mg, ecallantide 10 mg, placebo, placebo match for 30 mg ecallantide arm, placebo match for 10 mg ecallantide arm
- First posted
- 2011-04-28
- Last updated
- 2021-06-11
- Results first posted
- 2013-11-18
- Limitations and caveats
- The study was determined to be inadequately powered to detect a statistically significant difference between ecallantide and placebo for the primary efficacy endpoint, and therefore terminated early.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Efficacy of Ecallantide | 6 hours | 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 better" as assessed by health care provider using a five point scale • Stable vital signs (within an acceptable range) • Absence of stridor • Absence of dyspnea or use of accessory muscles during respiration • Absence of drooling • Able to drink without difficulty |
| Secondary | Time to Symptom Resolution Based on the Visual Analog Scale (VAS) | 6 hours | Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups. The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from "totally resolved" to "very severe". |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Efficacy of Ecallantide | 6 hours | Safety Population | participants | NUMBER |
| SECONDARY | Time to Symptom Resolution Based on the Visual Analog Scale (VAS) | 6 hours | Time to Symptom Resolution Based on the VAS (Safety Population) | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Efficacy of Ecallantide | Placebo | 13 | 95% Confidence Interval NA to NA | participants | |
| Safety and Efficacy of Ecallantide | Ecallantide 10 mg | 17 | 95% Confidence Interval -18.8 to 43.1 | participants | |
| Safety and Efficacy of Ecallantide | Ecallantide 30 mg | 17 | 95% Confidence Interval -15.9 to 45.9 | participants | |
| Safety and Efficacy of Ecallantide | Ecallantide 60 mg | 17 | 95% Confidence Interval -15.9 to 45.9 | participants | |
| Time to Symptom Resolution Based on the Visual Analog Scale (VAS) | Placebo | 0.50 | 95% Confidence Interval 0.25 to 1.50 | hours | |
| Time to Symptom Resolution Based on the Visual Analog Scale (VAS) | Ecallantide 10 mg | 0.30 | 95% Confidence Interval 0.25 to 0.73 | hours | |
| Time to Symptom Resolution Based on the Visual Analog Scale (VAS) | Ecallantide 30 mg | 0.27 | 95% Confidence Interval 0.23 to 1.00 | hours | |
| Time to Symptom Resolution Based on the Visual Analog Scale (VAS) | Ecallantide 60 mg | 0.50 | 95% Confidence Interval 0.22 to 2.02 | hours |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | STARTED | Ecallantide 10 mg | 20 | |
| Overall Study | STARTED | Ecallantide 30 mg | 19 | |
| Overall Study | STARTED | Ecallantide 60mg | 20 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | Ecallantide 10 mg | 20 | |
| Overall Study | COMPLETED | Ecallantide 30 mg | 19 | |
| Overall Study | COMPLETED | Ecallantide 60mg | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Ecallantide 10 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events196
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Ecallantide 10 mg | 0 | 20 | |
| other | Anemia | Blood and lymphatic system disorders | Ecallantide 30 mg | 0 | 19 | |
| other | Anemia | Blood and lymphatic system disorders | Ecallantide 60 mg | 0 | 19 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 1 | 18 | |
| other | Tachycardia | Cardiac disorders | Ecallantide 10 mg | 0 | 20 | |
| other | Tachycardia | Cardiac disorders | Ecallantide 30 mg | 0 | 19 | |
| other | Tachycardia | Cardiac disorders | Ecallantide 60 mg | 0 | 19 | |
| other | Tachycardia | Cardiac disorders | Placebo | 2 | 18 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ecallantide 10 mg | 0 | 20 | |
| other | Abdominal Pain | Gastrointestinal disorders | Ecallantide 30 mg | 0 | 19 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ecallantide 10 mg | ||
| Total, all-cause mortality | Ecallantide 30 mg | ||
| Total, all-cause mortality | Ecallantide 60 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ecallantide 10 mg | 7 | 20 |
| Total, other adverse events | Ecallantide 30 mg | 11 | 19 |
| Total, other adverse events | Ecallantide 60 mg | 12 | 19 |
| Total, other adverse events | Placebo | 8 | 18 |
| Total, serious adverse events | Ecallantide 10 mg | 6 | 20 |
| Total, serious adverse events | Ecallantide 30 mg | 8 | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25182544 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01343823
GET https://conductscience.org/api/trials/v1/NCT01343823/events?page=2