A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)

NCT00912093 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-06-11

Study results available
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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).

Conditions

Interventions

DRUG

Icatibant

Single subcutaneous injection of icatibant, 30 mg

DRUG

Placebo

Single subcutaneous injection of matching placebo

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-16
Primary Completion
2010-10-01
Completion
2010-10-01

Countries

  • United States
  • Australia
  • Canada
  • Hungary
  • Israel
  • Romania
  • Russia
  • South Africa
  • Ukraine

Study Locations

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Entities

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 NCT00912093 on ClinicalTrials.gov