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

NCT01313572 | Terminated Phase 3

• 1 other identifier: PGX-III-AP-002
• Study Type: interventional
• Target: 197
• Locations: 5 countries
• Sites: 86

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 (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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Myocardial Perfusion Imaging

Outcome Measures

Primary Outcomes (1)

• Presence of myocardial perfusion defect based on SPECT-MPI

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

Secondary Outcomes (1)

• Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI

  Up to 2 hours after administration of study drug in Period 2

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

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 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: BMS068645, 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (86)

Forest Investigative Site 138

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site 146

Phoenix, Arizona, 85020, United States

Location

Forest Investigative Site 113

Little Rock, Arkansas, 72204, United States

Location

Forest Investigative Site 148

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 154

Los Angeles, California, 90048, United States

Location

Forest Investigative Site 131

Mission Viejo, California, 92691, United States

Location

Forest Investigative Site 156

Denver, Colorado, 80206, United States

Location

Forest Investigative Site 108

New Haven, Connecticut, 06510, United States

Location

Forest Investigative Site 111

Newark, Delaware, 19713, United States

Location

Forest Investigative Site 101

Clearwater, Florida, 33756, United States

Location

Forest Investigative Site 163

Daytona Beach, Florida, 32117, United States

Location

Forest Investigative Site 135

Edgewater, Florida, 32141, United States

Location

Forest Investigative Site 102

Inverness, Florida, 34452, United States

Location

Forest Investigative Site 151

Jacksonville, Florida, 32209, United States

Location

Forest Investigative Site 105

Melbourne, Florida, 32901, United States

Location

Forest Investigative Site 143

Melbourne, Florida, 32901, United States

Location

Forest Investigative Site 137

Miami, Florida, 33136, United States

Location

Forest Investigative Site 103

Miami, Florida, 33173, United States

Location

Forest Investigative Site 123

Naples, Florida, 34119, United States

Location

Forest Investigative Site 161

Safety Harbor, Florida, 34695, United States

Location

Forest Investigative Site 118

Cumming, Georgia, 30041, United States

Location

Forest Investigative Site 119

Tucker, Georgia, 30084, United States

Location

Forest Investigative Site 166

Covington, Louisiana, 70433, United States

Location

Forest Investigative Site 109

Hammond, Louisiana, 70403, United States

Location

Forest Investigative Site 122

Slidell, Louisiana, 70458, United States

Location

Forest Investigative Site 121

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 124

Annapolis, Maryland, 21401, United States

Location

Forest Investigative Site 149

Hollywood, Maryland, 20636, United States

Location

Forest Investigative Site 104

Detroit, Michigan, 48201, United States

Location

Forest Investigative Site 134

Detroit, Michigan, 48202, United States

Location

Forest Investigative Site 159

Rochester, Minnesota, 55905, United States

Location

Forest Investigative Site 142

Kansas City, Missouri, 64114, United States

Location

Forest Investigative Site 162

New Brunswick, New Jersey, 08901, United States

Location

Forest Investigative Site 125

Albuquerque, New Mexico, 87108, United States

Location

Forest Investigative Site 110

New York, New York, 10032, United States

Location

Forest Investigative Site 153

Camp Hill, Pennsylvania, 17011, United States

Location

Forest Investigative Site 152

Pittsburgh, Pennsylvania, 15213, United States

Location

Forest Investigative Site 120

Wyomissing, Pennsylvania, 19610, United States

Location

Forest Investigative Site 145

Johnson City, Tennessee, 37604, United States

Location

Forest Investigative Site 140

Nashville, Tennessee, 37203, United States

Location

Forest Investigative Site 107

Houston, Texas, 77024, United States

Location

Forest Investigative Site 129

Houston, Texas, 77070, United States

Location

Forest Investigative Site 115

Plano, Texas, 75024, United States

Location

Forest Investigative Site 150

Tomball, Texas, 77375, United States

Location

Forest Investigative Site 144

Provo, Utah, 84604, United States

Location

Forest Investigative Site 205

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122AAL, Argentina

Location

Forest Investigative Site 208

Rosario, Santa Fe Province, S2000DIF, Argentina

Location

Forest Investigative Site 204

Rosario, Santa Fe Province, S2000ODA, Argentina

Location

Forest Investigative Site 209

Buenos Aires, 1177AEJ, Argentina

Location

Forest Investigative Site 212

Buenos Aires, 1201, Argentina

Location

Forest Investigative Site 211

Córdoba, X5000AAX, Argentina

Location

Forest Investigative Site 207

Córdoba, X5000JJS, Argentina

Location

Forest Investigative Site 203

Córdoba, X5003FGG, Argentina

Location

Forest Investigative Site 201

Godoy Cruz, M5501AAJ, Argentina

Location

Forest Investigative Site 202

Godoy Cruz, M5501AAJ, Argentina

Location

Forest Investigative Site 214

La Plata, B1925XAC, Argentina

Location

Forest Investigative Site 210

Mar del Plata, B7600FZD, Argentina

Location

Forest Investigative Site 213

San Isidro, B1642CAD, Argentina

Location

Forest Investigative Site 206

Santa Fe, S3000AOL, Argentina

Location

Forest Investigative Site 501

Aalst, 9300, Belgium

Location

Forest Investigative Site 503

Brussels, 1200, Belgium

Location

Forest Investigative Site 314

Curitiba, Paraná, 80010-030, Brazil

Location

Forest Investigative Site 312

Curitiba, Paraná, 80320-320, Brazil

Location

Forest Investigative Site 309

São José do Rio Preto, São Paulo, 15015-210, Brazil

Location

Forest Investigative Site 307

Belo Horizonte, 30130-100, Brazil

Location

Forest Investigative Site 308

Belo Horizonte, 30140-000, Brazil

Location

Forest Investigatie Site 301

Curitiba, 80050-010, Brazil

Location

Forest Investigative Site 306

Goiânia, 74823-470, Brazil

Location

Forest Investigative Site 310

Maceió, 57021-500, Brazil

Location

Forest Investigative Site 302

Porto Alegre, 90610-000, Brazil

Location

Forest Investigative Site 304

Recife, 52010-010, Brazil

Location

Forest Investigative Site 315

Rio de Janeiro, 22251-050, Brazil

Location

Forest Investigative Site 311

Rio de Janeiro, 22640-102, Brazil

Location

Forest Investigative Site 303

Salvador, 40050-410, Brazil

Location

Forest Investigative Site 305

São José do Rio Preto, 15015-205, Brazil

Location

Forest Investigative Site 313

São Paulo, 04012-180, Brazil

Location

Forest Investigative Site 316

São Paulo, 05403-000, Brazil

Location

Forest Investigative Site 402

Gouda, Bleuland, 2803 HH, Netherlands

Location

Forest Investigative Site 403

Apeldoorn, Lukas, 7334 DZ, Netherlands

Location

Forest Investigative Site 407

Amsterdam, 1061 AE, Netherlands

Location

Forest Investigative Site 405

Delft, 2625 AD, Netherlands

Location

Forest Investigative Site 401

Doetinchem, 7009 BL, Netherlands

Location

Forest Investigative Site 408

Hengelo, 7555 DL, Netherlands

Location

Forest Investigative Site 404

Hoogeveen, 7909 AA, Netherlands

Location

Forest Investigative Site 406

Maastricht, 6229 HX, Netherlands

Location

Forest Investigative Site 409

Rotterdam, 3045 PM, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

BMS-068645; 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: March 4, 2011
• First Posted: March 11, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

US (45); NL (9); BE (2); BR (16); AR (14)