Effect of dapagliflozin on flow-mediated dilation and blood pressure (DAPA-BP): a phase III, randomized, open-label, parallel group study in hypertensive patients with controlled type 2 diabetes - DAPA

AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA0 个研究点目标入组 55 人开始时间: 2019年2月25日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Inclusion criteria for the main study (short-term study):
•1.Provision of informed consent prior to any study specific procedures
•2.Men or post-menopausal women that express their willing to participate in the study by signing the informed consent
•3.Subjects aged 30-69 years (inclusive)
•4.T2DM patients with adequate glucose control (HbA1c<7.5%), achieved with any oral anti-hyperglycemic treatment, whose BP values are not at target (e.g. clinic BP >140/90 mmHg or home BP >135/85 mmHg despite a therapeutic dose of ACE-inhibitors
•Inclusion criteria for the substudy (acute study):
•1.Provision of informed consent prior to any study specific procedures
•2.Men or post-menopausal women that express their willing to participate in the study by signing the informed consent
•3.Subjects aged 30-69 years (inclusive)
•4.T2DM patients with adequate glucose control (HbA1c<7.5%) achieved with any oral anti-hyperglycemic treatment, but treatment-naïve for hypertension whose blood pressure values are not controlled (e.g. clinic BP >140/90 mmHg or home BP >135/85 mmHg), in whose according to guidelines antihypertensive treatment is not yet compelling
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Clinic BP values > 160/100 mmHg
•eGFR<60ml/min/1.73 m2
•Patients with NYHA III/IV heart failure
•Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
•Total bilirubin >2.0 mg/dL (34.2 µmol/L)
•Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
•Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (use of other diuretics, laxatives, chronic diarrhoea etc)
•History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin cancer
•Patients unable to give a valid informed consent;
•Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
•Patients who received any investigational new drug within the last 12 weeks;
•Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.

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