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NCT01919801 · ClinicalTrials.gov registry record · Phase 3
Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT01919801: Completed Phase 3 study, sponsored by Shire.
NCT01919801 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 118 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01919801, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study Summary
This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.
Primary Outcome
TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=ab
Interventions
- DRUG Placebo
- DRUG Icatibant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2013-12-02 |
| Est. Completion | 2015-08-22 |
| Phase | Phase 3 |
What the finished NCT01919801 record still lists
NCT01919801 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01919801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01919801 about?
NCT01919801 is a clinical study titled "Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema". This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.
What is the current status of trial NCT01919801?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2013-12-02. Estimated completion is 2015-08-22.
What interventions are being tested in trial NCT01919801?
The interventions under investigation include: Placebo (DRUG), Icatibant (DRUG).
Who is sponsoring clinical trial NCT01919801?
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 NCT01919801's enrollment target sits among peer trials
118 1641st of 2000 higher than 359 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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