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NCT00097695 · ClinicalTrials.gov registry record · Phase 3
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT00097695: Completed Phase 3 study, sponsored by Shire.
NCT00097695 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097695, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study 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).
Primary Outcome
The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current stat
Interventions
- DRUG Placebo
- DRUG Icatibant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2004-12-28 |
| Est. Completion | 2006-07-17 |
| Phase | Phase 3 |
What the finished NCT00097695 record still lists
NCT00097695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00097695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00097695 about?
NCT00097695 is a clinical study titled "Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema". 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).
What is the current status of trial NCT00097695?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2004-12-28. Estimated completion is 2006-07-17.
What interventions are being tested in trial NCT00097695?
The interventions under investigation include: Placebo (DRUG), Icatibant (DRUG).
Who is sponsoring clinical trial NCT00097695?
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 NCT00097695's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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