Efficacy and Safety Study of Azimilide on the Incidence o... | NCT01464476

Studies
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

Sponsor

Forest Laboratories

Status

Terminated

Last Update Posted

May 6, 2013Estimated

Enrollment

240Actual

Phase

Phase 3

Conditions

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Implantable Cardioverter Defibrillator

Interventions

Azimilide Dihydrochloride
Placebo

Countries

United States
Belgium
Canada
Czechia
Denmark
France
Germany
Israel
Italy
Netherlands
Poland
Spain
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

May 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Nov 1, 2011

First Submission Date that Met QC Criteria

Nov 2, 2011

First Posted Date

Nov 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2013

Last Update Posted Date

May 6, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azimilide	Experimental	Azimilide 75 mg film coated tablets	Drug: Azimilide Dihydrochloride
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azimilide Dihydrochloride	Drug	Azimilide 75 mg. Once daily, oral administration	Azimilide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time to first all-cause shock by the ICD	Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator	365 days
Time to first unplanned physician-office visit.	Time to the first unplanned physician-office visit.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David B Bharucha, MD, PhD	Forest Laboratories	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site 053		Birmingham	Alabama	35211	United States
Forest Investigative Site 048

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases