EUCTR2016-000172-19-DE进行中（未招募）1 期
Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients with Type 2 Diabetes - EMPA Hemodynamics
RWTH Aachen University for the Medical Faculty, represented by Center for Transitional & Clinical Research Aachen (CTC-A0 个研究点目标入组 44 人开始时间: 2016年11月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Type 2 diabetes
- •2.Serum levels of HbA1c = 6.5 %
- •3.Age = 18 years
- •4.Written informed consent prior to study participation
- •5. Participants of child-bearing age should use adequate contraception
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Type 1 diabetes
- •2.Systolic blood pressure = 180 mmHg, diastolic blood pressure = 100 mmHg
- •3.Age = 75 years
- •4.Pregnancy and lactating females.
- •5.Renal impairment (GFR < 30 ml/min/1.73 m2)
- •6.Liver disease (serum levels of AST, ALT or AP more than three times the upper limit of normal)
- •7.Uncontrolled thyroid disease
- •8.Endocrinopathies like Graves’ disease, acromegaly, Cushing’s disease
- •9.Hypertensive retinopathy or encephalopathy
- •10.Acute coronary syndrome, stroke or transient ischemic attack in last 6 weeks prior to randomization
- •11.The subject is mentally or legally incapacitated
- •12.The subject received an investigational drug within 30 days prior to inclusion into this study
- •13. Urinary tract infections or significant formation of residual urine in medical history
研究者
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