EUCTR2015-001501-14-FR进行中（未招募）1 期
Pilot study of aprepitant effect on aldosterone secretion in diabetic patient (diabetes mellitus) with hypertension associated with low renin - APHOS-02
Rouen University Hospital0 个研究点目标入组 20 人开始时间: 2016年1月29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
- 20
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
- •Male or menopausal female subjects;
- •Age ranging 18-30 years old;
- •Submitted to a social security regimen;
- •Agreeing to the study & Informed consent form signed;
- •Body mass index ([weight (kg)/height (m)]²) < 27;
- •No treatment received 6 weeks before inclusion;
- •No anomaly after: complete clinical examination, pulse and blood pressure measurement, ECG;
- •No biological abnormality after the following biological testing:
- •Hematology: white & red blood cells & platelets count, haemoglobin, hematocrit,
- •Blood biochemistry: sodium, potassium, chloride, bicarbonate, creatinine, urea,
- •Urinary biochemistry (24 h collection): cortisol, aldosterone,
- •Serologies: HIV, HBV, HCV,
- •No participation in a clinical trial 3 months ago before inclusion,
- •Subscription to national social security,
- •Signed informed consent.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Female subject potentially pregnant,
- •Subject younger than 18 year-old and older than 70 year-old,
- •Subject without diabetes condition or with diabetes but normal blood pressure (below 130/80 mmHg),
- •Subject with glycated hemoglobin HbA1c < 6.5% or >11%,
- •Subject with leuconeutropenia (neutrophils below 1700/mm3),
- •Subject with severe medical or surgical history,
- •Patients treated with drugs metabolized by CYP3A4 and CYP2C9: corticosteroids, vitamin K , hormonal contraceptives, tolbutamide, benzodiazepines, derived from ergot, antiepileptics, hypericum, macrolides, azole antifungals.
- •Patients treated with drugs interfering with the renin-angiotensin- aldosterone system : beta-blockers, diuretics , anti -aldosterone drugs , direct renin inhibitors , insulin,
- •type 2 diabetes patients with a vegetative autonomic neuropathy,
- •Patients with adrenal mass was diagnosed at imaging,
- •hepatic or renal impairment (defined respectively by secondary clinical and biological manifestations altered hepatocyte functions or estimated glomerular filtration rate less than 60 mL / min / 1.73 m2);nephrotic syndrome (defined by hypoalbuminemia less than 30 g / L associated with proteinuria at 3 grams / 24 hours);edematous syndrome (defined by the presence of edema of the lower limbs),
- •Orthostatic hypotension (defined by a decrease in systolic blood pressure of 20 mmHg and at least the diastolic blood pressure of 10 mmHg or more),
- •arrhythmias or cardiac conduction,
- •heart failure (NYHA class II minimum),
- •epilepsy,
- •serious psychiatric condition,
- •Severe allergic history, hypersensitivity to aprepitant,
- •People with hereditary problems of fructose intolerance, glucose malabsorption, galactose, or sucrase-isomaltase,
- •People with lactose intolerance,
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