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Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

NCT00097695 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-06-09

Study results available
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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).

Conditions

  • Angioedema

Interventions

DRUG

Icatibant

30 mg (3mL) subcutaneous icatibant injection in the abdominal region

DRUG

Placebo

Solution for injection, matched to study drug Single dose: 3 mL

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-28
Primary Completion
2006-07-17
Completion
2006-07-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00097695 on ClinicalTrials.gov