A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, COMPARATIVE, ACTIVE-CONTROLLED, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF FIXED-DOSE COMBINATION OF DAPAGLIFLOZIN 10 MG AND METOPROLOL 50 MG XR VERSUS ONLY METOPROLOL 50 MG XR IN PATIENTS WITH HEART FAILURE POST ACUTE MYOCARDIAL INFARCTION - NA

ERIS LIFESCIENCES LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

阶段: 3 期
状态: 招募中
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Subjects of either sex having age >18years at the time of screening.
•2. Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol.
•3. Subjects diagnosed established documented diagnosis of symptomatic HF [New York Heart Association (NYHA) functional class II-III] with recent history of ( <2months) post-acute myocardial infarction (MI) followed by PCI carried out within 24 hours of occurrence of acute MI with estimated survival time >1 year.
•4. Should have been under treatment with optimized standard doses of guideline directed medical therapy which may contain combination of drugs from medication classes suggested in standard guidelines for treatment of HF [â??diureticâ?? and â??ACE inhibitorâ?? OR â??ARBâ?? and a â??beta-blockerâ?? and a â??mineralocorticoid receptor antagonist (only if considered appropriate by the treating physician)â??]. Therapy should have been individually optimized and stable for >=4 weeks (this does not apply to diuretics).
•-Patients who have not received beta-blockers prior to Screening shall be initiated on low dose beta-blocker treatment followed by dose up titration during Screening Phase (Day -28 to Day 0).
•-Patients should demonstrate stable heart rate on Metoprolol 50mg daily dose at the time of randomization in 2 out of 3 measurements.
•-Most patients with heart failure require treatment with a diuretic to control sodium and water retention leading to volume overload. It is recognized that diuretic dosing may be titrated to symptoms, signs, weight and other information and may thus vary. Each patient should, however, be treated with a diuretic regimen aimed at achieving optimal fluid/volume status for that individual.
•-Patients in whom any additional pharmacological or device therapy is contemplated or should be considered, must not be enrolled until therapy has been optimized and is stable for >=4 weeks
•-Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated
•5. Increased N-terminal pro-B- levels at the time of screening.
•6. Mildly reduced or reduced ejection fraction <50% on clinical imaging at the time of screening:
•-If there is more than one assessment of LVEF the value from the most recent measurement should be used in assessing eligibility.
•-2D-ECHO reports from within last 8 weeks are acceptable. In case imaging reports are older, 2D-ECHO to be repeated locally at the time of screening to establish baseline.
•7. Females of non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females.

排除标准

•1. Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or SGLT2 Inhibitors
•2. Subjects with past history or present symptoms of Bradycardia [Pulse rate <60bpm] and/or Hypotension [SBP <110 mmHg and DBP <70mmHg] with or without treatment with beta-blockers at 2 out of 3 measurements either at Screening or Randomization.
•3. Subjects with history of Bronchial Asthma & COPD.
•4. Subjects with history or present symptoms of recurrent UTI infections.
•5.Subjects receiving treatment with SGLT2 inhibitors within 8 weeks prior to enrolment.
•6. Stroke or transient ischemic attack within 12 weeks prior to enrollment
•7. Type-1 Diabetes Mellitus patients
•8. Type-2 Diabetes Mellitus patients with frequent episodes of hypoglycemia [Patients with type 2 diabetes mellitus continue to take their glucose lowering therapy but doses could be adjusted as required. Specifically the doses of insulin and sulfonylureas could be reduced to minimize the risk of hypoglycemia]
•9. Current acute decompensated HF or hospitalization due to decompensated HF <8 weeks prior to enrolment.
•10. Cardiac CRT implantation within 12 weeks or intended to implant prior to enrollment
•11. Previous cardiac transplantation or implantation of a ventricular assisted device (VAD) or similar device, or implantation expected after randomization.
•12. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker.
•13. Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma) or any history of malignancy
•14. Subjects with clinically significant renal disorders:
•-Estimated glomerular filtration rate: <30 mL/min/1.73 m2)
•-Subjects with S. Creatinine values and S.BUN values >= 1.5 times the upper limit of normal.
•15. Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease [abnormal Liver Function Test with values more than 3 times the upper limit of normal].
•16. Subjects with EF <25% as per Simpsonâ??s method on 2D Echo.
•17. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than a first degree or significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.).
•18. Subjects with known significant respiratory/ liver/ kidney/ neurological diseases/ uncontrolled diabetes.
•19. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception.
•20. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigatorâ??s judgment.
•21.Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug.
•22.Subjects with known alcohol or drug abuse.
•23.Chronic use of Non-steroidal anti-inflammatory drugs (NSAIDS) as they cause fluid retention
•24.Subjects with known History or active HIV, Hepatitis B

研究者

发起方

ERIS LIFESCIENCES LIMITED

相似试验

进行中（未招募）

不适用

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF TWO LENALIDOMIDE DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA - CC-5013-CLL-001Relapsed or refractory CLL-B in patients previously treated with alkilating agents after failure of fludarabine treatmentMedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemia

EUCTR2006-004469-32-ITCELGENE CORPORATIO340

进行中（未招募）

1 期

Study of safety and efficacy of Hercules versus Herceptin® in patients with breast cancer

EUCTR2011-001965-42-LVMYLAN GmbH456

进行中（未招募）

1 期

Study of safety and efficacy of Hercules versus Herceptin® in patients with breast cancerHuman Epidermal Growth Factor Receptor 2 positive (HER2+) metastatic breast cancer (MBC)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000020826

EUCTR2011-001965-42-HUMYLAN GmbH456

尚未招募

不适用

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE III STUDY OF THE SAFETY AND EFFICACY OF HERCULES PLUS TAXANE VERSUS HERCEPTIN® PLUS TAXANE AS FIRST LINE THERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER-C50 Malignant neoplasm of breastMalignant neoplasm of breastC50

PER-062-14Mylan GmbH,

进行中（未招募）

1 期

EUCTR2011-001965-42-CZMYLAN GmbH456