Trials / Completed
CompletedNCT01843530
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Technical University of Munich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema. This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Berinert | |
| DRUG | Clemastin | |
| DRUG | Cortisone acetate | |
| DRUG | NaCl |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2018-10-05
- Completion
- 2019-09-30
- First posted
- 2013-04-30
- Last updated
- 2023-11-24
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01843530. Inclusion in this directory is not an endorsement.