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NCT01464476 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

A Phase 3 study, sponsored by Forest Laboratories.

Terminated
Registry status
Phase 3
Development phase
240
Enrollment target

NCT01464476: Clinical Trial Phase 3 study, sponsored by Forest Laboratories.

NCT01464476 is a Phase 3 study that was terminated before completion, run by Forest Laboratories. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01464476, a Phase 3 study, was terminated before completion, sponsored by Forest Laboratories.

TERMINATED
Registry status
Phase 3
Development phase
240 participants
Enrollment target

Study Summary

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

Primary Outcome

Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)

Interventions

  • DRUG Placebo
  • DRUG Azimilide Dihydrochloride

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2011-11
Est. Completion 2013-06
Phase Phase 3
Forest Laboratories

145 total trials

Why NCT01464476 stopped before completion

NCT01464476 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

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

NCT01464476 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01464476 about?

NCT01464476 is a clinical study titled "Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)". This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

What is the current status of trial NCT01464476?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2011-11. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01464476?

The interventions under investigation include: Placebo (DRUG), Azimilide Dihydrochloride (DRUG).

Who is sponsoring clinical trial NCT01464476?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01464476's enrollment target sits among peer trials

240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01464476, the US trial registry maintained by the National Library of Medicine. NCT01464476 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.