At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 84 enrolled
Drug / intervention
Icatibant +1 moredrug
Likely dose
Icatibant 30 mg (3 mL) subcutaneous injection in the abdominal regionAI-extracted
Key inclusion· 4
- ✓Age 18 years or older
- ✓Documented HAE Type I or II with confirmed C1-INH deficiency
- ✓Current edema in cutaneous, abdominal, and/or laryngeal areas
- ✓Moderate to severe edema per investigator assessment
Key exclusion· 7
- ✕Angioedema type other than HAE (e.g., acquired angioedema)
- ✕Participation in another clinical trial within the past month
- ✕Any pain medication since onset of current edema attack
- ✕C1-INH replacement therapy within 3 days of edema onset
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema
In Brief
A Phase 3 clinical trial evaluating Icatibant and Placebo for Angioedema. Completed, enrolled 84 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAngioedema
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2004
Enrollment StartDec 2004
Primary CompletionJul 2006
TodayJul 2026
First PostedNov 29, 2004
Enrollment StartDec 28, 2004
Primary CompletionJul 17, 2006
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.6 years ago
Interventions
Icatibantdrug
30 mg (3mL) subcutaneous icatibant injection in the abdominal region
Placebodrug
Solution for injection, matched to study drug Single dose: 3 mL