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Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

NCT01343823 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2021-06-11

Study results available
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Summary

A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Conditions

  • ACE Inhibitor Induced Angioedema

Interventions

DRUG

ecallantide 60 mg

Administered as two 3 mL SC injections, each containing 30 mg ecallantide

DRUG

ecallantide 30 mg

Administered as one 3 mL SC injection containing 30 mg ecallantide

DRUG

ecallantide 10 mg

Administered as one 3 mL SC injection containing 10 mg ecallantide.

DRUG

placebo

Administered as two SC 3 mL injections

DRUG

placebo match for 30 mg ecallantide arm

One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.

DRUG

placebo match for 10 mg ecallantide arm

One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.

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
2011-06-01
Primary Completion
2012-06-01
Completion
2012-06-01

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 NCT01343823 on ClinicalTrials.gov