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Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

NCT01919801 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-06-08

Study results available
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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.

Conditions

  • Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Interventions

DRUG

Icatibant

Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema

DRUG

Placebo

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-02
Primary Completion
2015-08-22
Completion
2015-08-22

Countries

  • United States
  • Canada
  • Israel
  • United Kingdom

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 NCT01919801 on ClinicalTrials.gov