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

NCT00990327 | Terminated Phase 3

• 1 other identifier: PGX-III-AP-001
• Study Type: interventional
• Target: 863
• Locations: 2 countries
• Sites: 122

Brief Summary

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 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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Myocardial Perfusion Imaging

Outcome Measures

Primary Outcomes (1)

• Presence of myocardial perfusion defect as based on SPECT-MPI

  Up to 2 hours after study drug administration in Period 1 and 2

Secondary Outcomes (1)

• Incidence and patient rated intensity of most commonly reported side effects (e.g. dyspnea, flushing, chest pain, headache) associated with use of adenosine compared to apadenoson in SPECT-MPI

  1 hour after Period 2 study drug administration

Study Arms (2)

Apadenoson

EXPERIMENTAL

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 or the active comparator: adenosine.

Drug: Apadenoson SPECT-MPI; Drug: Adenosine SPECT-MPI

Adenosine

ACTIVE COMPARATOR

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 or the active comparator: adenosine.

Drug: Apadenoson SPECT-MPI; Drug: Adenosine SPECT-MPI

Interventions

Apadenoson SPECT-MPI DRUG

Apadenoson single bolus IV injection 100 or 150 ug

Also known as: DPC-A78445-00, DPH-068645-01, ATL146e, DWH 146e

Adenosine; Apadenoson

Adenosine SPECT-MPI DRUG

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

Also known as: Adenoscan

Adenosine; Apadenoson

Eligibility Criteria

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

You may qualify if:

• High pretest probability of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

You may not qualify if:

• Ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
• Treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
• 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
• Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
• Subject with past medical history of hepatitis B or C, or recent hepatitis A
• Pretreatment hypotension (systolic BP \< 90 mm Hg) or tachycardia (HR \> 100 bpm)
• Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent

Sponsors & Collaborators

• Forest Laboratories: lead
• PPD Development, LP: collaborator

Study Sites (122)

Forest Investigative Site 152

Birmingham, Alabama, 35294, United States

Location

Forest Investigative Site 250

Mobile, Alabama, 36608, United States

Location

Forest Investigative Site 223

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site 191

Phoenix, Arizona, 85020, United States

Location

Forest Investigative Site 230

Jonesboro, Arkansas, 72401, United States

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Forest Investigative Site 153

Little Rock, Arkansas, 72204, United States

Location

Forest Investigative Site 108

La Mesa, California, 91942, United States

Location

Forest Investigative Site 111

Mission Viejo, California, 92691, United States

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Forest Investigative Site 234

Murrieta, California, 92562, United States

Location

Forest Investigative Site 146

Roseville, California, 95661, United States

Location

Forest Investigative Site 225

Sacramento, California, 95816, United States

Location

Forest Investigative Site 122

Sacramento, California, 95825, United States

Location

Forest Investigative Site 105

Santa Rosa, California, 95405, United States

Location

Forest Investigative Site 196

Walnut Creek, California, 94598, United States

Location

Forest Investigative Site 132

Hartford, Connecticut, 06102, United States

Location

Forest Investigative Site 102

Newark, Delaware, 19713, United States

Location

Forest Investigative Site 205

Daytona Beach, Florida, 32114, United States

Location

Forest Investigative Site 233

Edgewater, Florida, 32141, United States

Location

Forest Investigative Site 164

Gainesville, Florida, 32605, United States

Location

Forest Investigative Site 120

Jacksonville, Florida, 32207, United States

Location

Forest Investigative Site 198

Jacksonville, Florida, 32209, United States

Location

Forest Investigative Site 118

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 124

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 125

Jacksonville, Florida, 32258, United States

Location

Forest Investigative Site 126

Jacksonville Beach, Florida, 32250, United States

Location

Forest Investigative Site 180

Melbourne, Florida, 32901, United States

Location

Forest Investigative Site 183

Miami, Florida, 33136, United States

Location

Forest Investigative Site 106

Miami, Florida, 33173, United States

Location

Forest Investigative Site 201

Naples, Florida, 34119, United States

Location

Forest Investigative Site 240

Tampa, Florida, 33609, United States

Location

Forest Investigative Site 238

Wellington, Florida, 33449, United States

Location

Forest Investigative Site 155

Augusta, Georgia, 30912, United States

Location

Forest Investigative Site 199

Cumming, Georgia, 30041, United States

Location

Forest Investigative Site 204

Tucker, Georgia, 30084, United States

Location

Forest Investigative Site 116

Honolulu, Hawaii, 96813, United States

Location

Forest Investigative Site 137

Boise, Idaho, 83712, United States

Location

Forest Investigative Site 138

Boise, Idaho, 83712, United States

Location

Forest Investigative Site 227

Chicago, Illinois, 60612, United States

Location

Forest Investigative Site 228

Joliet, Illinois, 60435, United States

Location

Forest Investigative Site 173

Winfield, Illinois, 60190, United States

Location

Forest Investigative Site 113

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 168

Valparaiso, Indiana, 46383, United States

Location

Forest Investigative Site 171

West Des Moines, Iowa, 50266, United States

Location

Forest Investigative Site 133

Overland Park, Kansas, 66209, United States

Location

Forest Investigative Site 248

Crestview Hills, Kentucky, 41017, United States

Location

Forest Investigative Site 241

Owensboro, Kentucky, 42303, United States

Location

Forest Investigative Site 202

Alexandria, Louisiana, 71301, United States

Location

Forest Investigative Site 257

Covington, Louisiana, 70433, United States

Location

Forest Investigative Site 114

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 107

Scarborough, Maine, 04074, United States

Location

Forest Investigative Site 109

South Portland, Maine, 04106, United States

Location

Forest Investigative Site 193

Baltimore, Maryland, 21208, United States

Location

Forest investigative Site 197

Westminster, Maryland, 21157, United States

Location

Forest Investigative Site 143

Detroit, Michigan, 48202, United States

Location

Forest Investigative Site 207

Petoskey, Michigan, 49770, United States

Location

Forest Investigative Site 177

Saint Louis Park, Minnesota, 55416, United States

Location

Forest Investigative Site 131

Tupelo, Mississippi, 38801, United States

Location

Forest Investigative Site 176

Kansas City, Missouri, 64132, United States

Location

Forest Investigative Site 159

St Louis, Missouri, 63110, United States

Location

Forest Investigative Site 188

Missoula, Montana, 59802, United States

Location

Forest Investigative Site 115

Albany, New York, 12205, United States

Location

Forest Investigative Site 212

Buffalo, New York, 14215, United States

Location

Forest Investigative Site 165

Kingston, New York, 12401, United States

Location

Forest Investigative Site 224

Manhasset, New York, 11030, United States

Location

Forest Investigative Site 139

Massapequa, New York, 11758, United States

Location

Forest Investigative Site 208

Raleigh, North Carolina, 27610, United States

Location

Forest Investigative Site 249

Sanford, North Carolina, 27330, United States

Location

Forest Investigative Site 214

Fargo, North Dakota, 58122, United States

Location

Forest Investigative Site 235

Akron, Ohio, 44304, United States

Location

Forest Investigative Site163

Columbus, Ohio, 43210, United States

Location

Forest Investigative Site 161

Columbus, Ohio, 43214, United States

Location

Forest Investigative Site 156

Lorain, Ohio, 44053, United States

Location

Forest Investigative Site 185

Sandusky, Ohio, 44870, United States

Location

Forest Investigative Site 101

Westlake, Ohio, 44145, United States

Location

Forest Investigative Site 182

Oklahoma City, Oklahoma, 73109, United States

Location

Forest Investigative Site 190

Bend, Oregon, 97701, United States

Location

Forest Investigative Site 217

Portland, Oregon, 97239, United States

Location

Forest Investigative Site 213

Camp Hill, Pennsylvania, 17011, United States

Location

Forest Investigative Site 154

Philadelphia, Pennsylvania, 19102, United States

Location

Forest Investigative Site 134

Philadelphia, Pennsylvania, 19140, United States

Location

Forest Investigative Site 218

Philadelphia, Pennsylvania, 19141, United States

Location

Forest Investigative Site 160

Pittsburgh, Pennsylvania, 15213, United States

Location

Forest Investigative Site 187

Sellersville, Pennsylvania, 18960, United States

Location

Forest Investigative Site 117

Wyomissing, Pennsylvania, 19610, United States

Location

Forest Investigative Site 149

Charleston, South Carolina, 29425, United States

Location

Forest Investigative Site 172

Simpsonville, South Carolina, 29681, United States

Location

Forest Investigative Site 229

Spartanburg, South Carolina, 29302, United States

Location

Forest Investigative Site 167

Johnson City, Tennessee, 37604, United States

Location

Forest Investigative Site 192

Johnson City, Tennessee, 37604, United States

Location

Forest Investigative Site 128

Amarillo, Texas, 79106, United States

Location

Forest Investigative Site 252

Grapevine, Texas, 76051, United States

Location

Forest Investigative Site 200

McKinney, Texas, 75069, United States

Location

Forest Investigative Site 181

Plano, Texas, 75024, United States

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Forest Investigative Site 253

San Antonio, Texas, 78215, United States

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Forest Investigative Site 186

Sugar Land, Texas, 77479, United States

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Forest Investigative Site 231

Tomball, Texas, 77375, United States

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Forest Investigative Site 232

Tomball, Texas, 77375, United States

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Forest Investigative Site 236

Provo, Utah, 84604, United States

Location

Forest Investigative Site 210

Charlottesville, Virginia, 22908, United States

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Forest Investigative Site 110

Roanoke, Virginia, 24014, United States

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Forest Investigative Site 151

Seattle, Washington, 98195, United States

Location

Forest Investigative Site 142

Spokane, Washington, 99204, United States

Location

Forest Investigative Site 144

Madison, Wisconsin, 53715, United States

Location

Forest Investigative Site 306

Salvador, Estado de Bahia, 41148-900, Brazil

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Forest Investigative Site 307

Curitiba, Paraná, 80010-030, Brazil

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Forest Investigative Site 308

Belo Horizonte - MG, 30150-221, Brazil

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Forest Investigative Site 317

Brasília - DF, 70390-700, Brazil

Location

Forest Investigative Site 311

Campinas, 13060-803, Brazil

Location

Forest Investigative Site 313

Curitiba, 80050-010, Brazil

Location

Forest Investigative Site 305

Curitiba, 83430-000, Brazil

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Forest Investigative Site 314

Curitiba - PR, 80320-320, Brazil

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Forest Investigative Site 316

Niterói, 24020-350, Brazil

Location

Forest Investigative Site 309

Passo Fundo - RS, 99010-080, Brazil

Location

Forest Investigative Site 318

Porto Alegre - RS, 90020-090, Brazil

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Forest Investigative Site 310

Porto Alegre - RS, 90035-903, Brazil

Location

Forest Investigative Site 315

Rio de Janeiro, 22251-030, Brazil

Location

Forest Investigative Site 319

Rio de Janeiro - RJ, 22240-006, Brazil

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Forest Investigative Site 304

Rio de Janeiro - RJ, 22280-020, Brazil

Location

Forest Investigative Site 301

Salvador - BA, 41810-010, Brazil

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Forest Investigative Site 303

São José, 88103-460, Brazil

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Forest Investigative Site 302

São Paulo - SP, 04012-180, Brazil

Location

Forest Investigative Site 312

São Paulo - SP, 05403-000, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

ATL 146e; Adenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David B Bharucha, MD, PhD, FACC

  Forest Laboratories

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 6, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

US (103); BR (19)