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)

NCT01464476 | Terminated Phase 3 DMC

• 1 other identifier: AZM-MD-302
• Study Type: interventional
• Target: 240
• Locations: 13 countries
• Sites: 138

Brief 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)

Conditions

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Implantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (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)

  365 days

Secondary Outcomes (2)

• Time to first all-cause shock by the ICD

  365 days

• Time to first unplanned physician-office visit.

  365 days

Study Arms (2)

Azimilide

EXPERIMENTAL

Azimilide 75 mg film coated tablets

Drug: Azimilide Dihydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Azimilide Dihydrochloride DRUG

Azimilide 75 mg. Once daily, oral administration

Azimilide

Placebo DRUG

Dose-matched placebo. Once daily, oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (138)

Forest Investigative Site 053

Birmingham, Alabama, 35211, United States

Location

Forest Investigative Site 048

Huntsville, Alabama, 35801, United States

Location

Forest Investigative Site 013

Phoenix, Arizona, 85013, United States

Location

Forest Investigative Site 110

Los Angeles, California, 99048, United States

Location

Forest Investigative Site 022

Merced, California, 95340, United States

Location

Forest Investigative Site 060

Colorado Springs, Colorado, 80909, United States

Location

Forest Investigative Site 090

Littleton, Colorado, 80712, United States

Location

Forest Investigative Site 041

Newark, Delaware, 19718, United States

Location

Forest Investigative Site 113

Hollywood, Florida, 33021, United States

Location

Forest Investigative Site 010

Jacksonville, Florida, 32204, United States

Location

Forest Investigative Site 035

Lakeland, Florida, 33805, United States

Location

Forest Investigative Site 044

Port Charlotte, Florida, 33952, United States

Location

Forest Investigative Site 062

Rockledge, Florida, 32955, United States

Location

Forest Investigative Site 082

Safety Harbor, Florida, 34695, United States

Location

Forest Investigative Site 006

Zephyrhills, Florida, 33542, United States

Location

Forest Investigative Site 123

Augusta, Georgia, 30901, United States

Location

Forest Investigative Site 092

Boise, Idaho, 83712, United States

Location

Forest Investigative Site 012

Bloomington, Indiana, 47402, United States

Location

Forest Investigative Site 068

Indianapolis, Indiana, 46237, United States

Location

Forest Investigative Site 087

South Bend, Indiana, 46601, United States

Location

Forest Investigative Site 063

Houma, Louisiana, 70360, United States

Location

Forest Investigative Site 050

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 030

Baltimore, Maryland, 21201, United States

Location

Forest Investigative Site 058

Baltimore, Maryland, 21237, United States

Location

Forest Investigative Site 052

Lanham, Maryland, 20706, United States

Location

Forest Investigative Site 118

Silver Spring, Maryland, 20903, United States

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Forest Investigative Site 015

Boston, Massachusetts, 02215, United States

Location

Forest Investigative Site 091

Brighton, Massachusetts, 02135, United States

Location

Forest Investigative Site 020

Saginaw, Michigan, 48601, United States

Location

Forest Investigative Site 085

Southfield, Michigan, 48075, United States

Location

Forest Investigative Site 079

Troy, Michigan, 48085, United States

Location

Forest Investigative Site 034

Ypsilanti, Michigan, 48197, United States

Location

Forest Investigative Site 121

Tupelo, Mississippi, 38801, United States

Location

Forest Investigative Site 088

St Louis, Missouri, 63110, United States

Location

Forest Investigative Site 100

St Louis, Missouri, 63125, United States

Location

Forest Investigative Site 055

Englewood, New Jersey, 07631, United States

Location

Forest Investigative Site 059

Ridgewood, New Jersey, 07450, United States

Location

Forest Investigative Site 106

Warren Township, New Jersey, 07059, United States

Location

Forest Investigative Site 112

Albuquerque, New Mexico, 87102, United States

Location

Forest Investigative Site 018

Albany, New York, 12205, United States

Location

Forest Investigative Site 069

Albany, New York, 12211, United States

Location

Forest Investigative Site 045

New York, New York, 10021, United States

Location

Forest Investigative Site 122

New York, New York, 10032, United States

Location

Forest Investigative Site 075

Williamsville, New York, 14221, United States

Location

Forest Investigative Site 089

Chapel Hill, North Carolina, 27599, United States

Location

Forest Investigative Site 116

Greensboro, North Carolina, 27401, United States

Location

Forest Investigative Site 070

Canton, Ohio, 44708, United States

Location

Forest Investigative Site 064

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 124

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 043

Columbus, Ohio, 43214, United States

Location

Forest Investigative Site 083

Kettering, Ohio, 45429, United States

Location

Forest Investigative Site 109

Toledo, Ohio, 43615, United States

Location

Forest Investigative Site 119

Oklahoma City, Oklahoma, 73120, United States

Location

Forest Investigative Site 003

Tulsa, Oklahoma, 74104, United States

Location

Forest Investigative Site 056

Camp Hill, Pennsylvania, 17011, United States

Location

Forest Investigative Site 081

Erie, Pennsylvania, 16502, United States

Location

Forest Investigative Site 008

Erie, Pennsylvania, 16507, United States

Location

Forest Investigative Site 024

Hershey, Pennsylvania, 17033, United States

Location

Forest Investigative Site 095

Philadelphia, Pennsylvania, 19141, United States

Location

Forest Investigative Site 005

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Forest Investigative Site 107

Yardley, Pennsylvania, 19067, United States

Location

Forest Investigative Site 046

York, Pennsylvania, 17403, United States

Location

Forest Investigative Site 084

Providence, Rhode Island, 02903, United States

Location

Forest Investigative Site 066

Florence, South Carolina, 29501, United States

Location

Forest Investigative Site 073

Greenville, South Carolina, 29607, United States

Location

Forest Investigative Site 014

Rapid City, South Dakota, 57701, United States

Location

Forest Investigative Site 094

Sioux Falls, South Dakota, 57108, United States

Location

Forest Investigative Site 029

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 028

Dallas, Texas, 75390, United States

Location

Forest Investigative Site 007

Fort Worth, Texas, 76104, United States

Location

Forest Investigative Site 111

Fort Worth, Texas, 76104, United States

Location

Forest Investigative Site 125

Houston, Texas, 77030, United States

Location

Forest Investigative Site 076

Houston, Texas, 77094, United States

Location

Forest Investigative Site 074

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 016

Chesapeake, Virginia, 23320, United States

Location

Forest Investigative Site 004

Falls Church, Virginia, 22042, United States

Location

Forest Investigative Site 117

Lynchburg, Virginia, 24501, United States

Location

Forest Investigative Site 065

Newport News, Virginia, 23601, United States

Location

Forest Investigative Site 072

Richmond, Virginia, 23219, United States

Location

Forest Investigative Site 023

Roanoke, Virginia, 24104, United States

Location

Forest Investigative Site 071

Green Bay, Wisconsin, 54301, United States

Location

Forest Investigative Site 042

Madison, Wisconsin, 53715, United States

Location

Forest Investigative Site 049

Milwaukee, Wisconsin, 53215, United States

Location

Forest Investigative Site 302

Bruges, 8000, Belgium

Location

Forest Investigative Site 303

Charleroi, 6000, Belgium

Location

Forest Investigative Site 300

Leuven, 3000, Belgium

Location

Forest Investigative Site 304

Liège, 4000, Belgium

Location

Forest Investigative Site 301

Yvoir, 5530, Belgium

Location

Forest Investigative Site 264

Edmonton, Alberta, T5H 3V9, Canada

Location

Forest Investigative Site 269

Vancouver, British Columbia, V5Z1M9, Canada

Location

Forest Investigative Site 252

Victoria, British Columbia, V8R 4R2, Canada

Location

Forest Investigative Site 267

Hamilton, Ontario, L8L 2X2, Canada

Location

Forest Investigative Site 253

Kingston, Ontario, K7L2V7, Canada

Location

Forest Investigative Site 259

Toronto, Ontario, M4N 3M5, Canada

Location

Forest Investigative Site 263

Toronto, Ontario, M5B 1N9, Canada

Location

Forest Investigative Site 254

Montreal, Quebec, H2W 1T8, Canada

Location

Forest Investigative Site 250

Montreal, Quebec, H3G1A4, Canada

Location

Forest Investigative Site 270

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Forest Investigative Site 262

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Forest Investigative Site 750

Brno, 65691, Czechia

Location

Forest Investigative Site 753

České Budějovice, 37001, Czechia

Location

Forest Investigative Site 751

Olomouc, 77520, Czechia

Location

Forest Investigative Site 754

Prague, 15030, Czechia

Location

Forest Investigative Site 752

Sokolska, 0581, Czechia

Location

Forest Investigative Site 852

Aalborg, DK-9100, Denmark

Location

Forest Investigative Site 850

Copenhagen, DK-2100, Denmark

Location

Forest Investigative Site 854

Esbjerg, DK6700, Denmark

Location

Forest Investigative Site 853

Hellerup, DK-2900, Denmark

Location

Forest Investigative Site 851

Odense, DK-5000, Denmark

Location

Forest Investigative Site 353

Grenoble, 38043, France

Location

Forest Investigative Site 354

Lille, 59037, France

Location

Forest Investigative Site 350

Montpellier, 34295, France

Location

Forest Investigative Site 358

Nantes, 44800, France

Location

Forest Investigative Site 357

Pessac, 33604, France

Location

Forest Investigative Site 405

Berlin, 14050, Germany

Location

Forest Investigative Site 402

Göttingen, 37099, Germany

Location

Forest Investigative Site 410

Heidelberg, 69120, Germany

Location

Forest Investigative Site 406

Ludwigshafen, 67063, Germany

Location

Forest Investigative Site 401

Mannheim, D-68167, Germany

Location

Forest Investigative Site 450

Ashkelon, 78278, Israel

Location

Forest Investigative Site 453

Jerusalem, 91120, Israel

Location

Forest Investigative Site 452

Tel Aviv, 64239, Israel

Location

Forest Investigative Site 451

Tel Litwinsky, 52621, Israel

Location

Forest Investigative Site 504

Ancona, 41060, Italy

Location

Forest Investigative Site 502

Catania, 95124, Italy

Location

Forest Investigative Site 552

Breda, 4818 CK, Netherlands

Location

Forest Investigative Site 550

Eindhoven, 5623, Netherlands

Location

Forest Investigative Site 555

Zwolle, 8011 JW, Netherlands

Location

Forest Investigative Site 706

Gdansk, 80-952, Poland

Location

Forest Investigative Site 705

Gdynia, 81-423, Poland

Location

Forest Investigative Site 604

Barcelona, 08036, Spain

Location

Forest Investigative Site 601

Málaga, 29010, Spain

Location

Forest Investigative Site 800

Lund, 22185, Sweden

Location

Forest Investigative Site 805

Örebro, 70185, Sweden

Location

Forest Investigative Site 804

Stockholm, 11883, Sweden

Location

Forest Investigative Site 802

Stockholm, 17176, Sweden

Location

Forest Investigative Site 801

Uppsala, 75185, Sweden

Location

Forest Investigative Site 803

Västerås, 72189, Sweden

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Interventions

azimilide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David B Bharucha, MD, PhD

  Forest Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

ES (2); BE (5); FR (5); PL (2); US (83); DE (5); CA (11); CZ (5); DK (5); IT (2); NL (3); IL (4); SE (6)