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NCT00912093 · ClinicalTrials.gov registry record · Phase 3
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT00912093: Completed Phase 3 study, sponsored by Shire.
NCT00912093 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00912093, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
Primary Outcome
Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and
Interventions
- DRUG Placebo
- DRUG Icatibant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2009-07-16 |
| Est. Completion | 2010-10-01 |
| Phase | Phase 3 |
What the finished NCT00912093 record still lists
NCT00912093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00912093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00912093 about?
NCT00912093 is a clinical study titled "A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)". This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
What is the current status of trial NCT00912093?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2009-07-16. Estimated completion is 2010-10-01.
What interventions are being tested in trial NCT00912093?
The interventions under investigation include: Placebo (DRUG), Icatibant (DRUG).
Who is sponsoring clinical trial NCT00912093?
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 NCT00912093's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 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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