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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01313572
Other study ID # PGX-III-AP-002
Secondary ID
Status Terminated
Phase Phase 3
First received March 4, 2011
Last updated April 27, 2012
Start date August 2011
Est. completion date April 2012

Study information

Verified date April 2012
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 197
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
Apadenoson SPECT-MPI
Apadenoson single bolus IV injection 100 or 150 ug
Adenosine SPECT-MPI
Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute

Locations

Country Name City State
Argentina Forest Investigative Site 209 Buenos Aires
Argentina Forest Investigative Site 212 Ciudad Autonoma de Buenos Aires
Argentina Forest Investigative Site 205 Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina Forest Investigative Site 203 Cordoba
Argentina Forest Investigative Site 207 Cordoba
Argentina Forest Investigative Site 211 Córdoba
Argentina Forest Investigative Site 202 Godoy Cruz
Argentina Forest Investigative Site 201 Godoy Cruz,
Argentina Forest Investigative Site 214 La Plata
Argentina Forest Investigative Site 210 Mar del Plata
Argentina Forest Investigative Site 204 Rosario Santa Fé
Argentina Forest Investigative Site 208 Rosario Santa Fe
Argentina Forest Investigative Site 213 San Isidro
Argentina Forest Investigative Site 206 Santa fe
Belgium Forest Investigative Site 501 Aalst
Belgium Forest Investigative Site 503 Bruxelles
Brazil Forest Investigative Site 307 Belo Horizonte
Brazil Forest Investigative Site 308 Belo Horizonte
Brazil Forest Investigatie Site 301 Curitiba
Brazil Forest Investigative Site 312 Curitiba Paraná
Brazil Forest Investigative Site 314 Curitiba Parana
Brazil Forest Investigative Site 306 Goiânia
Brazil Forest Investigative Site 310 Maceió
Brazil Forest Investigative Site 302 Porto Alegre
Brazil Forest Investigative Site 304 Recife
Brazil Forest Investigative Site 311 Rio de Janeiro
Brazil Forest Investigative Site 315 Rio de Janeiro
Brazil Forest Investigative Site 303 Salvador
Brazil Forest Investigative Site 305 São José do Rio Preto
Brazil Forest Investigative Site 309 São José do Rio Preto São Paulo
Brazil Forest Investigative Site 313 Sao Paulo
Brazil Forest Investigative Site 316 São Paulo
Netherlands Forest Investigative Site 407 Amsterdam
Netherlands Forest Investigative Site 403 Apeldoorn Lukas
Netherlands Forest Investigative Site 405 Delft
Netherlands Forest Investigative Site 401 Doetinchem
Netherlands Forest Investigative Site 402 Gouda Bleuland
Netherlands Forest Investigative Site 408 Hengelo
Netherlands Forest Investigative Site 404 Hoogeveen
Netherlands Forest Investigative Site 406 Maastricht
Netherlands Forest Investigative Site 409 Rotterdam
United States Forest Investigative Site 125 Albuquerque New Mexico
United States Forest Investigative Site 124 Annapolis Maryland
United States Forest Investigative Site 121 Auburn Maine
United States Forest Investigative Site 148 Beverly Hills California
United States Forest Investigative Site 153 Camp Hill Pennsylvania
United States Forest Investigative Site 101 Clearwater Florida
United States Forest Investigative Site 166 Covington Louisiana
United States Forest Investigative Site 118 Cumming Georgia
United States Forest Investigative Site 163 Daytona Beach Florida
United States Forest Investigative Site 156 Denver Colorado
United States Forest Investigative Site 104 Detroit Michigan
United States Forest Investigative Site 134 Detroit Michigan
United States Forest Investigative Site 135 Edgewater Florida
United States Forest Investigative Site 109 Hammond Louisiana
United States Forest Investigative Site 149 Hollywood Maryland
United States Forest Investigative Site 107 Houston Texas
United States Forest Investigative Site 129 Houston Texas
United States Forest Investigative Site 102 Inverness Florida
United States Forest Investigative Site 151 Jacksonville Florida
United States Forest Investigative Site 145 Johnson City, Tennessee
United States Forest Investigative Site 142 Kansas City Missouri
United States Forest Investigative Site 113 Little Rock Arkansas
United States Forest Investigative Site 154 Los Angeles California
United States Forest Investigative Site 105 Melbourne Florida
United States Forest Investigative Site 143 Melbourne Florida
United States Forest Investigative Site 103 Miami Florida
United States Forest Investigative Site 137 Miami Florida
United States Forest Investigative Site 131 Mission Viejo California
United States Forest Investigative Site 123 Naples Florida
United States Forest Investigative Site 140 Nashville Tennessee
United States Forest Investigative Site 162 New Brunswick New Jersey
United States Forest Investigative Site 108 New Haven Connecticut
United States Forest Investigative Site 110 New York New York
United States Forest Investigative Site 111 Newark Delaware
United States Forest Investigative Site 138 Phoenix Arizona
United States Forest Investigative Site 146 Phoenix Arizona
United States Forest Investigative Site 152 Pittsburgh Pennsylvania
United States Forest Investigative Site 115 Plano Texas
United States Forest Investigative Site 144 Provo Utah
United States Forest Investigative Site 159 Rochester Minnesota
United States Forest Investigative Site 161 Safety Harbor Florida
United States Forest Investigative Site 122 Slidell Louisiana
United States Forest Investigative Site 150 Tomball Texas
United States Forest Investigative Site 119 Tucker Georgia
United States Forest Investigative Site 120 Wyomissing Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Forest Laboratories PPD

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of myocardial perfusion defect based on SPECT-MPI Up to 2 hours after study drug administration in Period 1 and Period 2 No
Secondary 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 Yes
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