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)

Cardiovascular Diseases Clinical Trial

— SHIELD-2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01464476
• Other study ID #: AZM-MD-302
• Status: Terminated
• Phase: Phase 3
• First received: November 1, 2011
• Last updated: May 2, 2013
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2013
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlDenmark: Danish Health and Medicines AuthorityDenmark: The Danish National Committee on Biomedical Research EthicsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des MédecinsGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Office for Radiation ProtectionIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products Agency
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Azimilide Dihydrochloride
Azimilide 75 mg. Once daily, oral administration
• Placebo
Dose-matched placebo. Once daily, oral administration

Locations

Country	Name	City	State
Belgium	Forest Investigative Site 302	Brugge
Belgium	Forest Investigative Site 303	Charleroi
Belgium	Forest Investigative Site 300	Leuven
Belgium	Forest Investigative Site 304	Liège
Belgium	Forest Investigative Site 301	Yvoir
Canada	Forest Investigative Site 264	Edmonton	Alberta
Canada	Forest Investigative Site 267	Hamilton	Ontario
Canada	Forest Investigative Site 253	Kingston	Ontario
Canada	Forest Investigative Site 250	Montreal	Quebec
Canada	Forest Investigative Site 254	Montreal	Quebec
Canada	Forest Investigative Site 262	Saskatoon	Saskatchewan
Canada	Forest Investigative Site 270	Sherbrooke	Quebec
Canada	Forest Investigative Site 259	Toronto	Ontario
Canada	Forest Investigative Site 263	Toronto	Ontario
Canada	Forest Investigative Site 269	Vancouver	British Columbia
Canada	Forest Investigative Site 252	Victoria	British Columbia
Czech Republic	Forest Investigative Site 750	Brno
Czech Republic	Forest Investigative Site 753	Ceské Budejovice
Czech Republic	Forest Investigative Site 751	Olomouc
Czech Republic	Forest Investigative Site 754	Prague
Czech Republic	Forest Investigative Site 752	Sokolska
Denmark	Forest Investigative Site 852	Aalborg
Denmark	Forest Investigative Site 850	Copenhagen
Denmark	Forest Investigative Site 854	Esbjerg
Denmark	Forest Investigative Site 853	Hellerup
Denmark	Forest Investigative Site 851	Odense
France	Forest Investigative Site 353	Grenoble
France	Forest Investigative Site 354	Lille
France	Forest Investigative Site 350	Montpellier
France	Forest Investigative Site 358	Nantes
France	Forest Investigative Site 357	Pessac
Germany	Forest Investigative Site 405	Berlin
Germany	Forest Investigative Site 402	Gottingen
Germany	Forest Investigative Site 410	Heidelberg
Germany	Forest Investigative Site 406	Ludwigshafen
Germany	Forest Investigative Site 401	Mannheim
Israel	Forest Investigative Site 450	Ashkelon
Israel	Forest Investigative Site 453	Jerusalem
Israel	Forest Investigative Site 452	Tel Aviv
Israel	Forest Investigative Site 451	Tel Hashomer
Italy	Forest Investigative Site 504	Ancona
Italy	Forest Investigative Site 502	Catania
Netherlands	Forest Investigative Site 552	Breda
Netherlands	Forest Investigative Site 550	Eindhoven
Netherlands	Forest Investigative Site 555	Zwolle
Poland	Forest Investigative Site 706	Gdansk
Poland	Forest Investigative Site 705	Gdynia
Spain	Forest Investigative Site 604	Barcelona
Spain	Forest Investigative Site 601	Malaga
Sweden	Forest Investigative Site 800	Lund
Sweden	Forest Investigative Site 805	Orebro
Sweden	Forest Investigative Site 802	Stockholm
Sweden	Forest Investigative Site 804	Stockholm
Sweden	Forest Investigative Site 801	Uppsala
Sweden	Forest Investigative Site 803	Vasteras
United States	Forest Investigative Site 018	Albany	New York
United States	Forest Investigative Site 069	Albany	New York
United States	Forest Investigative Site 112	Albuquerque	New Mexico
United States	Forest Investigative Site 050	Auburn	Maine
United States	Forest Investigative Site 123	Augusta	Georgia
United States	Forest Investigative Site 030	Baltimore	Maryland
United States	Forest Investigative Site 058	Baltimore	Maryland
United States	Forest Investigative Site 053	Birmingham	Alabama
United States	Forest Investigative Site 012	Bloomington	Indiana
United States	Forest Investigative Site 092	Boise	Idaho
United States	Forest Investigative Site 015	Boston	Massachusetts
United States	Forest Investigative Site 091	Brighton	Massachusetts
United States	Forest Investigative Site 056	Camp Hill	Pennsylvania
United States	Forest Investigative Site 070	Canton	Ohio
United States	Forest Investigative Site 089	Chapel Hill	North Carolina
United States	Forest Investigative Site 016	Chesapeake	Virginia
United States	Forest Investigative Site 064	Cincinnati	Ohio
United States	Forest Investigative Site 124	Cincinnati	Ohio
United States	Forest Investigative Site 060	Colorado Springs	Colorado
United States	Forest Investigative Site 043	Columbus	Ohio
United States	Forest Investigative Site 029	Corpus Christi	Texas
United States	Forest Investigative Site 028	Dallas	Texas
United States	Forest Investigative Site 055	Englewood,	New Jersey
United States	Forest Investigative Site 008	Erie	Pennsylvania
United States	Forest Investigative Site 081	Erie	Pennsylvania
United States	Forest Investigative Site 004	Falls Church	Virginia
United States	Forest Investigative Site 066	Florence	South Carolina
United States	Forest Investigative Site 111	Fort Worth	Texas
United States	Forest Investigative Site 007	Fort Worth,	Texas
United States	Forest Investigative Site 071	Green Bay	Wisconsin
United States	Forest Investigative Site 116	Greensboro	North Carolina
United States	Forest Investigative Site 073	Greenville	South Carolina
United States	Forest Investigative Site 024	Hershey	Pennsylvania
United States	Forest Investigative Site 113	Hollywood	Florida
United States	Forest Investigative Site 063	Houma	Louisiana
United States	Forest Investigative Site 076	Houston	Texas
United States	Forest Investigative Site 125	Houston	Texas
United States	Forest Investigative Site 048	Huntsville	Alabama
United States	Forest Investigative Site 068	Indianapolis	Indiana
United States	Forest Investigative Site 010	Jacksonville	Florida
United States	Forest Investigative Site 083	Kettering	Ohio
United States	Forest Investigative Site 035	Lakeland	Florida
United States	Forest Investigative Site 052	Lanham	Maryland
United States	Forest Investigative Site 090	Littleton	Colorado
United States	Forest Investigative Site 110	Los Angeles	California
United States	Forest Investigative Site 117	Lynchburg	Virginia
United States	Forest Investigative Site 042	Madison	Wisconsin
United States	Forest Investigative Site 022	Merced	California
United States	Forest Investigative Site 049	Milwaukee	Wisconsin
United States	Forest Investigative Site 045	New York	New York
United States	Forest Investigative Site 122	New York	New York
United States	Forest Investigative Site 041	Newark	Delaware
United States	Forest Investigative Site 065	Newport News	Virginia
United States	Forest Investigative Site 119	Oklahoma City	Oklahoma
United States	Forest Investigative Site 095	Philadelphia	Pennsylvania
United States	Forest Investigative Site 013	Phoenix	Arizona
United States	Forest Investigative Site 044	Port Charlotte	Florida
United States	Forest Investigative Site 084	Providence	Rhode Island
United States	Forest Investigative Site 014	Rapid City	South Dakota
United States	Forest Investigative Site 072	Richmond	Virginia
United States	Forest Investigative Site 059	Ridgewood	New Jersey
United States	Forest Investigative Site 023	Roanoke	Virginia
United States	Forest Investigative Site 062	Rockledge	Florida
United States	Forest Investigative Site 082	Safety Harbor	Florida
United States	Forest Investigative Site 020	Saginaw	Michigan
United States	Forest Investigative Site 074	San Antonio	Texas
United States	Forest Investigative Site 118	Silver Spring	Maryland
United States	Forest Investigative Site 094	Sioux Falls	South Dakota
United States	Forest Investigative Site 087	South Bend	Indiana
United States	Forest Investigative Site 085	Southfield	Michigan
United States	Forest Investigative Site 088	St. Louis	Missouri
United States	Forest Investigative Site 100	St. Louis	Missouri
United States	Forest Investigative Site 109	Toledo	Ohio
United States	Forest Investigative Site 079	Troy	Michigan
United States	Forest Investigative Site 003	Tulsa	Oklahoma
United States	Forest Investigative Site 121	Tupelo	Mississippi
United States	Forest Investigative Site 106	Warren	New Jersey
United States	Forest Investigative Site 005	Wilkes-Barre	Pennsylvania
United States	Forest Investigative Site 075	Williamsville	New York
United States	Forest Investigative Site 107	Yardley	Pennsylvania
United States	Forest Investigative Site 046	York	Pennsylvania
United States	Forest Investigative Site 034	Ypsilanti	Michigan
United States	Forest Investigative Site 006	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time to first all-cause shock by the ICD	Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator	365 days	Yes
Secondary	Time to first unplanned physician-office visit.	Time to the first unplanned physician-office visit.	365 days	Yes