Subjects who are planned to be undergoing a clinically indicated cardiac catheterization
Conditions
Interventions
investigational material(s)
Generic name etc : Regadenoson
INN of investigational material : Regadenoson
Therapeutic category code : 799 Agents for not mainly purpose of therapeutic, n.e.c.
Dosage and
Sponsors
Nihon Medi-Physics Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included un the study will be subjects who: 1. Are undergoing a clinically indicated cardiac catheterization for evaluation and/ or treatment of suspected ischemic heart disease 2. Have a normal ECG or an abnormal ECG not considered to reflect ongoing or frequently recurrent ischemia at screening
Exclusion criteria
Exclusion criteria: Exclusion from the study will be subjects who: 1. Have a history of coronary revascularization by either PCI or CABG within 6 months prior to dosing 2. Have a documented history of acute myocardial infarction or unstable angina within 1 month of dosing 3. Have uncontrolled hypertension 4. Have LVEF < 35% 5. Have aortic stenosis with valve area < 1.5 cm2 6. Have decompensated CHF and/ or New York Heart Association Class IV CHF 7. Have hypertrophic obstructive cardiomyopathy 8. Have asthma , chronic obstructive pulmonary disease or other reactive airway disease for which they are currently receiving treatment 9. Have a history of cardiac transplantation 10. Have a documented history or family history of long QT syndrome 11. Have a documented hypersensitivity to adenosine 12. Have a second- or third-degree AV block 13. Have a sinus node disease, such as sick sinus syndrome or symptomatic bradycardia 14. Have a severe hypotension 15. Known or suspected bronchoconstrictive or bronchospastic lung disease 16. Are unwilling to refrain from all long-acting vasodilating medications 17. Have demonstrable allergy to aminophylline, including allergy to its components (ethylenediamine and theophylline)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficacy The time (in seconds) that the ratio of APV to baseline APV following administration of NMB46 will be at least 2.0-fold. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1.Efficacy 2.Safety 1.Efficacy The ratio of peak APV to baseline APV following administration of NMB46 The time required for reaching the peak APV after NMB46 administration (Ratio of peak APV to baseline APV following administration of NMB46) / (ratio of peak APV to baseline APV following administration of adenosine) 2.Safety Adverse event Vital sign 12-lead ECG Laboratory tests Examination | — |
Countries
Japan
Outcome results
None listed