NCT01464476 (SHIELD-2) is a Phase 3 clinical trial of Azimilide Dihydrochloride in Arrhythmias, Cardiac, sponsored by Forest Laboratories.

Who is sponsoring NCT01464476?

NCT01464476 is sponsored by Forest Laboratories.

What drugs are being tested in NCT01464476?

Interventions in NCT01464476: Azimilide Dihydrochloride, Placebo.

What condition does NCT01464476 study?

NCT01464476 studies Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator.

Is NCT01464476 still recruiting?

NCT01464476 is currently terminated. Last updated 2 May 2013.

Last reviewed 2013-05-02 · How we verify

NCT01464476: SHIELD-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator

Terminated Phase 3 Last updated 2 May 2013

What this trial tests

Phase 3 trial testing Azimilide Dihydrochloride in Arrhythmias, Cardiac in 240 participants. Terminated before completion.

Timeline

1 November 2011

Primary endpoint
1 May 2013

1 June 2013

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	240
Start date	1 November 2011
Primary completion	1 May 2013
Estimated completion	1 June 2013
Sites	138 locations across United States, Belgium, Canada, Czechia, Denmark, France, Germany, Israel

Drugs / interventions tested

Azimilide Dihydrochloride — full drug profile →
Placebo

Conditions studied

Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
Heart Diseases — all drugs for Heart Diseases →
Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Implantable Cardioverter Defibrillator — all drugs for Implantable Cardioverter Defibrillator →

Sponsor

Forest Laboratories — full company profile →

Who can join

18 and older, any sex, with Arrhythmias, Cardiac or Heart Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Time to first cardiovascular event
Time frame: 365 days
Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Arrhythmias, Cardiac

Currently open trials in the same condition.

NCT07276139 — PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD · active not recruiting
NCT06954610 — Cardiac Assessment for Recurrent Stroke Risk Evaluation in Atrial Fibrillation · recruiting
NCT06360939 — Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease · NA · recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT06358391 — To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Pu · NA · recruiting

Other Forest Laboratories trials

Trials by the same sponsor.

NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage · completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer · Phase 2 · terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode · Phase 3 · completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres · Phase 3 · completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01464476 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 2 May 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01464476.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing