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NCT01574248 · ClinicalTrials.gov registry record · Phase 4

Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

A Phase 4 study, sponsored by Vanderbilt University Medical Center.

Terminated
Registry status
Phase 4
Development phase
33
Enrollment target

NCT01574248: Clinical Trial Phase 4 study, sponsored by Vanderbilt University Medical Center.

NCT01574248 is a Phase 4 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01574248, a Phase 4 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.

TERMINATED
Registry status
Phase 4
Development phase
33 participants
Enrollment target

Study Summary

Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other body parts. This study will evaluate the effectiveness of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the condition.

Primary Outcome

Time interval between initiation of treatment and when there is no symptom, by visual analog scale \<1 cm. Data provided are for worst symptom.

Interventions

  • OTHER Placebo
  • DRUG icatibant

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2011-08
Est. Completion 2016-02
Phase Phase 4

Why NCT01574248 stopped before completion

NCT01574248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01574248 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01574248 about?

NCT01574248 is a clinical study titled "Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema". Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other bod...

What is the current status of trial NCT01574248?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2011-08. Estimated completion is 2016-02.

What interventions are being tested in trial NCT01574248?

The interventions under investigation include: Placebo (OTHER), icatibant (DRUG).

Who is sponsoring clinical trial NCT01574248?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01574248's enrollment target sits among peer trials

33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT01574248, the US trial registry maintained by the National Library of Medicine. NCT01574248 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.