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Arrhythmias, CardiacPhase 3SHIELD-2NCT01464476

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 testing Azimilide Dihydrochloride in people with Arrhythmias, Cardiac and Heart Diseases, run by Forest Laboratories at 138 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Azimilide Dihydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
138 sitesin 13 countries
Study dates
Nov 2011to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.
  • Have a left ventricular ejection fraction <= 0.40

Who cannot join

  • Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;
  • Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;
  • Have a history of Torsade de Pointes or heart transplantation
  • Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;
  • Are currently taking systemic Class I or other Class III antiarrhythmic drugs
  • Are currently taking systemic drugs that prolong the QT interval
  • If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study

Trial locations and contacts

138 sites in 13 countries.

138 sites in 13 countries

United States83 sites

  • Forest Investigative Site 018

    Albany, New York, 12205

  • Forest Investigative Site 069

    Albany, New York, 12211

  • Forest Investigative Site 112

    Albuquerque, New Mexico, 87102

  • Forest Investigative Site 050

    Auburn, Maine, 04210

  • Forest Investigative Site 123

    Augusta, Georgia, 30901

  • Forest Investigative Site 030

    Baltimore, Maryland, 21201

  • Forest Investigative Site 058

    Baltimore, Maryland, 21237

  • Forest Investigative Site 053

    Birmingham, Alabama, 35211

  • Forest Investigative Site 012

    Bloomington, Indiana, 47402

  • Forest Investigative Site 092

    Boise, Idaho, 83712

  • Forest Investigative Site 015

    Boston, Massachusetts, 02215

  • Forest Investigative Site 091

    Brighton, Massachusetts, 02135

  • Forest Investigative Site 056

    Camp Hill, Pennsylvania, 17011

  • Forest Investigative Site 070

    Canton, Ohio, 44708

  • Forest Investigative Site 089

    Chapel Hill, North Carolina, 27599

  • Forest Investigative Site 016

    Chesapeake, Virginia, 23320

  • Forest Investigative Site 064

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 124

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 060

    Colorado Springs, Colorado, 80909

  • Forest Investigative Site 043

    Columbus, Ohio, 43214

  • Forest Investigative Site 029

    Corpus Christi, Texas, 78404

  • Forest Investigative Site 028

    Dallas, Texas, 75390

  • Forest Investigative Site 055

    Englewood, New Jersey, 07631

  • Forest Investigative Site 081

    Erie, Pennsylvania, 16502

  • Forest Investigative Site 008

    Erie, Pennsylvania, 16507

  • Forest Investigative Site 004

    Falls Church, Virginia, 22042

  • Forest Investigative Site 066

    Florence, South Carolina, 29501

  • Forest Investigative Site 007

    Fort Worth, Texas, 76104

  • Forest Investigative Site 111

    Fort Worth, Texas, 76104

  • Forest Investigative Site 071

    Green Bay, Wisconsin, 54301

  • Forest Investigative Site 116

    Greensboro, North Carolina, 27401

  • Forest Investigative Site 073

    Greenville, South Carolina, 29607

  • Forest Investigative Site 024

    Hershey, Pennsylvania, 17033

  • Forest Investigative Site 113

    Hollywood, Florida, 33021

  • Forest Investigative Site 063

    Houma, Louisiana, 70360

  • Forest Investigative Site 125

    Houston, Texas, 77030

  • Forest Investigative Site 076

    Houston, Texas, 77094

  • Forest Investigative Site 048

    Huntsville, Alabama, 35801

  • Forest Investigative Site 068

    Indianapolis, Indiana, 46237

  • Forest Investigative Site 010

    Jacksonville, Florida, 32204

  • Forest Investigative Site 083

    Kettering, Ohio, 45429

  • Forest Investigative Site 035

    Lakeland, Florida, 33805

  • Forest Investigative Site 052

    Lanham, Maryland, 20706

  • Forest Investigative Site 090

    Littleton, Colorado, 80712

  • Forest Investigative Site 110

    Los Angeles, California, 99048

  • Forest Investigative Site 117

    Lynchburg, Virginia, 24501

  • Forest Investigative Site 042

    Madison, Wisconsin, 53715

  • Forest Investigative Site 022

    Merced, California, 95340

  • Forest Investigative Site 049

    Milwaukee, Wisconsin, 53215

  • Forest Investigative Site 045

    New York, New York, 10021

  • Forest Investigative Site 122

    New York, New York, 10032

  • Forest Investigative Site 041

    Newark, Delaware, 19718

  • Forest Investigative Site 065

    Newport News, Virginia, 23601

  • Forest Investigative Site 119

    Oklahoma City, Oklahoma, 73120

  • Forest Investigative Site 095

    Philadelphia, Pennsylvania, 19141

  • Forest Investigative Site 013

    Phoenix, Arizona, 85013

  • Forest Investigative Site 044

    Port Charlotte, Florida, 33952

  • Forest Investigative Site 084

    Providence, Rhode Island, 02903

  • Forest Investigative Site 014

    Rapid City, South Dakota, 57701

  • Forest Investigative Site 072

    Richmond, Virginia, 23219

  • Forest Investigative Site 059

    Ridgewood, New Jersey, 07450

  • Forest Investigative Site 023

    Roanoke, Virginia, 24104

  • Forest Investigative Site 062

    Rockledge, Florida, 32955

  • Forest Investigative Site 082

    Safety Harbor, Florida, 34695

  • Forest Investigative Site 020

    Saginaw, Michigan, 48601

  • Forest Investigative Site 074

    San Antonio, Texas, 78229

  • Forest Investigative Site 118

    Silver Spring, Maryland, 20903

  • Forest Investigative Site 094

    Sioux Falls, South Dakota, 57108

  • Forest Investigative Site 087

    South Bend, Indiana, 46601

  • Forest Investigative Site 085

    Southfield, Michigan, 48075

  • Forest Investigative Site 088

    St Louis, Missouri, 63110

  • Forest Investigative Site 100

    St Louis, Missouri, 63125

  • Forest Investigative Site 109

    Toledo, Ohio, 43615

  • Forest Investigative Site 079

    Troy, Michigan, 48085

  • Forest Investigative Site 003

    Tulsa, Oklahoma, 74104

  • Forest Investigative Site 121

    Tupelo, Mississippi, 38801

  • Forest Investigative Site 106

    Warren Township, New Jersey, 07059

  • Forest Investigative Site 005

    Wilkes-Barre, Pennsylvania, 18711

  • Forest Investigative Site 075

    Williamsville, New York, 14221

  • Forest Investigative Site 107

    Yardley, Pennsylvania, 19067

  • Forest Investigative Site 046

    York, Pennsylvania, 17403

  • Forest Investigative Site 034

    Ypsilanti, Michigan, 48197

  • Forest Investigative Site 006

    Zephyrhills, Florida, 33542

Other trials in United States

Canada11 sites

  • Forest Investigative Site 264

    Edmonton, Alberta, T5H 3V9

  • Forest Investigative Site 267

    Hamilton, Ontario, L8L 2X2

  • Forest Investigative Site 253

    Kingston, Ontario, K7L2V7

  • Forest Investigative Site 254

    Montreal, Quebec, H2W 1T8

  • Forest Investigative Site 250

    Montreal, Quebec, H3G1A4

  • Forest Investigative Site 262

    Saskatoon, Saskatchewan, S7N 0W8

  • Forest Investigative Site 270

    Sherbrooke, Quebec, J1H 5N4

  • Forest Investigative Site 259

    Toronto, Ontario, M4N 3M5

  • Forest Investigative Site 263

    Toronto, Ontario, M5B 1N9

  • Forest Investigative Site 269

    Vancouver, British Columbia, V5Z1M9

  • Forest Investigative Site 252

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Sweden6 sites

  • Forest Investigative Site 800

    Lund, 22185

  • Forest Investigative Site 805

    Örebro, 70185

  • Forest Investigative Site 804

    Stockholm, 11883

  • Forest Investigative Site 802

    Stockholm, 17176

  • Forest Investigative Site 801

    Uppsala, 75185

  • Forest Investigative Site 803

    Västerås, 72189

Other trials in Sweden

Belgium5 sites

  • Forest Investigative Site 302

    Bruges, 8000

  • Forest Investigative Site 303

    Charleroi, 6000

  • Forest Investigative Site 300

    Leuven, 3000

  • Forest Investigative Site 304

    Liège, 4000

  • Forest Investigative Site 301

    Yvoir, 5530

Other trials in Belgium

Czechia5 sites

  • Forest Investigative Site 750

    Brno, 65691

  • Forest Investigative Site 753

    České Budějovice, 37001

  • Forest Investigative Site 751

    Olomouc, 77520

  • Forest Investigative Site 754

    Prague, 15030

  • Forest Investigative Site 752

    Sokolska, 0581

Other trials in Czechia

Denmark5 sites

  • Forest Investigative Site 852

    Aalborg, DK-9100

  • Forest Investigative Site 850

    Copenhagen, DK-2100

  • Forest Investigative Site 854

    Esbjerg, DK6700

  • Forest Investigative Site 853

    Hellerup, DK-2900

  • Forest Investigative Site 851

    Odense, DK-5000

Other trials in Denmark

France5 sites

  • Forest Investigative Site 353

    Grenoble, 38043

  • Forest Investigative Site 354

    Lille, 59037

  • Forest Investigative Site 350

    Montpellier, 34295

  • Forest Investigative Site 358

    Nantes, 44800

  • Forest Investigative Site 357

    Pessac, 33604

Other trials in France

Germany5 sites

  • Forest Investigative Site 405

    Berlin, 14050

  • Forest Investigative Site 402

    Göttingen, 37099

  • Forest Investigative Site 410

    Heidelberg, 69120

  • Forest Investigative Site 406

    Ludwigshafen, 67063

  • Forest Investigative Site 401

    Mannheim, D-68167

Other trials in Germany

Israel4 sites

  • Forest Investigative Site 450

    Ashkelon, 78278

  • Forest Investigative Site 453

    Jerusalem, 91120

  • Forest Investigative Site 452

    Tel Aviv, 64239

  • Forest Investigative Site 451

    Tel HaShomer, 52621

Other trials in Israel

Netherlands3 sites

  • Forest Investigative Site 552

    Breda, 4818 CK

  • Forest Investigative Site 550

    Eindhoven, 5623

  • Forest Investigative Site 555

    Zwolle, 8011 JW

Other trials in Netherlands

Italy2 sites

  • Forest Investigative Site 504

    Ancona, 41060

  • Forest Investigative Site 502

    Catania, 95124

Other trials in Italy

Poland2 sites

  • Forest Investigative Site 706

    Gdansk, 80-952

  • Forest Investigative Site 705

    Gdynia, 81-423

Other trials in Poland

Spain2 sites

  • Forest Investigative Site 604

    Barcelona, 08036

  • Forest Investigative Site 601

    Málaga, 29010

Other trials in Spain

About this study

Official title: 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

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)

Being tested
Azimilide Dihydrochloride, Placebo
Medical subject headings
Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azimilide DihydrochlorideDrug

    Azimilide 75 mg. Once daily, oral administration

  • PlaceboDrug

    Dose-matched placebo. Once daily, oral administration

Study groups in NCT01464476
Study groupRoleWhat they receive
AzimilideExperimentalAzimilide 75 mg film coated tablets
Receives: Drug: Azimilide Dihydrochloride
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first cardiovascular event

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

    Measured: 365 days

Secondary outcomes (2)

  1. Time to first all-cause shock by the ICD

    Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator

    Measured: 365 days

  2. Time to first unplanned physician-office visit.

    Time to the first unplanned physician-office visit.

    Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2013 (estimated)
  4. Study completionJun 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01464476
Sponsor's protocol ID
AZM-MD-302
Acronym
SHIELD-2
Status last verified
May 2013
First submitted
1 Nov 2011
Last updated
6 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azimilide Dihydrochloride in people with Arrhythmias, Cardiac and Heart Diseases, run by Forest Laboratories at 138 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Canada, Sweden, Belgium, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first cardiovascular event (time frame: 365 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.

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