drugset / Trial / NCT01343823
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
Timeline
- Start
- 2011-06-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
Outcome
Outcome not reported
Stopped: “Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ecallantide | Protein / enzyme biologic | 10 mg | Subcutaneous |
| Comparator | ecallantide | Protein / enzyme biologic | 30 mg | Subcutaneous |
| Comparator | ecallantide | Protein / enzyme biologic | 60 mg | Subcutaneous |