Ranolazine to treat early cardiotoxicity induced by antitumor drugs - ND

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.0 个研究点开始时间: 2010年1月28日最近更新: 2015年7月10日

试验速览

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•1. Age 18-70 years 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. total serum bilirubin < 2.0 mg/dL 4. serum creatinine level < 2.0 mg/dL 5. normal ECG 6. LVEF ≥ 50% at echocardiography 7. normal E/A and DcT at echocardiography 8. no significant perfusion defect at SPECT 9. able to release written informed consent 10. women of childbearing potential must have a negative serum pregnancy test; they agree on avoiding pregnancy by adequate contraceptive precautions (e.g., double barrier methods), or abstinence, during both chemotherapy and subsequent ranolazine therapy (if applicable) 11. male patients are informed of the mutagenic and embryotoxic effects of chemotherapy; in agreement with their partner, they accept not to concur in a pregnancy by adopting adequate contraceptive precautions, or abstinence, during chemotherapy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. pregnancy or nursing 2. women with HER-2+ breast cancer requiring post-chemotherapy trastuzumab 3. prior chemotherapy or medastinal irradiation 4. patients with mediastinal lymphoma liable to irradiation after completing chemotherapy 5. long QTc, LVEF < 50% or altered E/A, or significant perfusion defects, at screening ECG, echocardiography, and SPECT 6. hypertension 7. any clinically documented heart disease 8. any other medical conditions that required treatment over the past 3 months with ACEI, ABR, Ca2+ antagonists, β blockers, nitrates, diuretics 9. diabetes mellitus 10. dislipidemia 11. BMI > 30 12. prior steroid pulse therapy for unrelated diseases 13. severe renal impairment 14. moderate or severe hepatic impairment 15. cerebral vascular accidents within the past 3 months 16. severe psychopathy 17. chronic obstructive lung disease

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