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Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI

NCT ID: NCT01313572

Last Updated: 2012-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.

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Detailed Description

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Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging (SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most subjects. This is a multi-center, randomized double-blind study to compare the tolerability and effectiveness of apadenoson to adenosine (Adenoscan®) in SPECT-MPI. Subjects who are clinical candidates for SPECT-MPI will be enrolled to undergo two sequential SPECT-MPI studies. The first study will use adenosine as the stress agent in approximately 1250 subjects. Eligible subjects will then be randomized in a 1:1 assignment ratio to receive a second SPECT-MPI using either adenosine or apadenoson as the pharmacologic stress agent, with the goal of obtaining a total of 670 subjects who complete both studies. The agreement of the results from the two adenosine:adenosine stress tests will be compared to that from the adenosine:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Apadenoson

In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson

Group Type EXPERIMENTAL

Apadenoson SPECT-MPI

Intervention Type DRUG

Apadenoson single bolus IV injection 100 or 150 ug

Adenosine SPECT-MPI

Intervention Type DRUG

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute

Adenosine

In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with the active comparator: adenosine.

Group Type ACTIVE_COMPARATOR

Apadenoson SPECT-MPI

Intervention Type DRUG

Apadenoson single bolus IV injection 100 or 150 ug

Adenosine SPECT-MPI

Intervention Type DRUG

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute

Interventions

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Apadenoson SPECT-MPI

Apadenoson single bolus IV injection 100 or 150 ug

Intervention Type DRUG

Adenosine SPECT-MPI

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute

Intervention Type DRUG

Other Intervention Names

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BMS068645 DPC-A78445-00 DPH-068645-01 ATL146e DWH 146e Adenoscan

Eligibility Criteria

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Inclusion Criteria

* Referred for a clinically indicated rest/pharmacologic stress SPECT-MPI test
* High pretest probability (90% or greater) of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

Exclusion Criteria

* Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
* Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
* History or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
* Hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
* Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
* Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David B Bharucha, MD, PhD, FACC

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 138

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 146

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 113

Little Rock, Arkansas, United States

Site Status

Forest Investigative Site 148

Beverly Hills, California, United States

Site Status

Forest Investigative Site 154

Los Angeles, California, United States

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Forest Investigative Site 131

Mission Viejo, California, United States

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Forest Investigative Site 156

Denver, Colorado, United States

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Forest Investigative Site 108

New Haven, Connecticut, United States

Site Status

Forest Investigative Site 111

Newark, Delaware, United States

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Forest Investigative Site 101

Clearwater, Florida, United States

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Forest Investigative Site 163

Daytona Beach, Florida, United States

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Forest Investigative Site 135

Edgewater, Florida, United States

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Forest Investigative Site 102

Inverness, Florida, United States

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Forest Investigative Site 151

Jacksonville, Florida, United States

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Forest Investigative Site 105

Melbourne, Florida, United States

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Forest Investigative Site 143

Melbourne, Florida, United States

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Forest Investigative Site 137

Miami, Florida, United States

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Forest Investigative Site 103

Miami, Florida, United States

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Forest Investigative Site 123

Naples, Florida, United States

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Forest Investigative Site 161

Safety Harbor, Florida, United States

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Forest Investigative Site 118

Cumming, Georgia, United States

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Forest Investigative Site 119

Tucker, Georgia, United States

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Forest Investigative Site 166

Covington, Louisiana, United States

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Forest Investigative Site 109

Hammond, Louisiana, United States

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Forest Investigative Site 122

Slidell, Louisiana, United States

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Forest Investigative Site 121

Auburn, Maine, United States

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Forest Investigative Site 124

Annapolis, Maryland, United States

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Forest Investigative Site 149

Hollywood, Maryland, United States

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Forest Investigative Site 104

Detroit, Michigan, United States

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Forest Investigative Site 134

Detroit, Michigan, United States

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Forest Investigative Site 159

Rochester, Minnesota, United States

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Forest Investigative Site 142

Kansas City, Missouri, United States

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Forest Investigative Site 162

New Brunswick, New Jersey, United States

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Forest Investigative Site 125

Albuquerque, New Mexico, United States

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Forest Investigative Site 110

New York, New York, United States

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Forest Investigative Site 153

Camp Hill, Pennsylvania, United States

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Forest Investigative Site 152

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 120

Wyomissing, Pennsylvania, United States

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Forest Investigative Site 145

Johnson City, Tennessee, United States

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Forest Investigative Site 140

Nashville, Tennessee, United States

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Forest Investigative Site 107

Houston, Texas, United States

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Forest Investigative Site 129

Houston, Texas, United States

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Forest Investigative Site 115

Plano, Texas, United States

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Forest Investigative Site 150

Tomball, Texas, United States

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Forest Investigative Site 144

Provo, Utah, United States

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Forest Investigative Site 205

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Forest Investigative Site 208

Rosario, Santa Fe Province, Argentina

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Forest Investigative Site 204

Rosario, Santa Fe Province, Argentina

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Forest Investigative Site 209

Buenos Aires, , Argentina

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Forest Investigative Site 212

Buenos Aires, , Argentina

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Forest Investigative Site 211

Córdoba, , Argentina

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Forest Investigative Site 207

Córdoba, , Argentina

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Forest Investigative Site 203

Córdoba, , Argentina

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Forest Investigative Site 201

Godoy Cruz, , Argentina

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Forest Investigative Site 202

Godoy Cruz, , Argentina

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Forest Investigative Site 214

La Plata, , Argentina

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Forest Investigative Site 210

Mar del Plata, , Argentina

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Forest Investigative Site 213

San Isidro, , Argentina

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Forest Investigative Site 206

Santa Fe, , Argentina

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Forest Investigative Site 501

Aalst, , Belgium

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Forest Investigative Site 503

Brussels, , Belgium

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Forest Investigative Site 314

Curitiba, Paraná, Brazil

Site Status

Forest Investigative Site 312

Curitiba, Paraná, Brazil

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Forest Investigative Site 309

São José do Rio Preto, São Paulo, Brazil

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Forest Investigative Site 307

Belo Horizonte, , Brazil

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Forest Investigative Site 308

Belo Horizonte, , Brazil

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Forest Investigatie Site 301

Curitiba, , Brazil

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Forest Investigative Site 306

Goiânia, , Brazil

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Forest Investigative Site 310

Maceió, , Brazil

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Forest Investigative Site 302

Porto Alegre, , Brazil

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Forest Investigative Site 304

Recife, , Brazil

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Forest Investigative Site 315

Rio de Janeiro, , Brazil

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Forest Investigative Site 311

Rio de Janeiro, , Brazil

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Forest Investigative Site 303

Salvador, , Brazil

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Forest Investigative Site 305

São José do Rio Preto, , Brazil

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Forest Investigative Site 313

São Paulo, , Brazil

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Forest Investigative Site 316

São Paulo, , Brazil

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Forest Investigative Site 402

Gouda, Bleuland, Netherlands

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Forest Investigative Site 403

Apeldoorn, Lukas, Netherlands

Site Status

Forest Investigative Site 407

Amsterdam, , Netherlands

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Forest Investigative Site 405

Delft, , Netherlands

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Forest Investigative Site 401

Doetinchem, , Netherlands

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Forest Investigative Site 408

Hengelo, , Netherlands

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Forest Investigative Site 404

Hoogeveen, , Netherlands

Site Status

Forest Investigative Site 406

Maastricht, , Netherlands

Site Status

Forest Investigative Site 409

Rotterdam, , Netherlands

Site Status

Countries

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United States Argentina Belgium Brazil Netherlands

Other Identifiers

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PGX-III-AP-002

Identifier Type: -

Identifier Source: org_study_id

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