EUCTR2010-022308-34-GB进行中（未招募）不适用
Eplerenone in Metabolic Syndrome: An investigation into the effects of Eplerenone on perivascular adipose tissue and small artery tone in obesity - Eplerenone in Metabolic Syndrome
Central Manchester Foundation Hospitals Trust0 个研究点开始时间: 2011年3月30日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •• Participants will have obesity: Waist girth > 102cm (40 inches) in men or > 94cm (37 inches) in women • In addition participants will have 3 or more components of the metabolic syndrome o Fasting plasma glucose = 6.1mmol/L o Serum triglycerides = 1.7mmolL o Serum High Density Lipoprotein (HDL) cholesterol < 1.04mmol/L o Blood pressure >130/85mmHg or treated blood pressure • Participants will be aged between 30 and 65 years of age • Patients with normal platelet count (150-400 x 109 per litre).
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant / lactating mothers • Diagnosed diabetes mellitus • Hypersensitivity to eplerenone or any of the excipients • Patients with serum potassium level > 5.5 mmol/L at initiation • Patients with moderate to severe renal insufficiency (creatinine clearance < 50 mL/min) • Patients with severe hepatic insufficiency (Child-Pugh Class C) • Patients taking a-blockers for hypertension • Patients receiving potassium-sparing diuretics or potassium-supplements • Patients taking strong inhibitors of CYP 3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) • Patients taking: Lithium, Tricyclic anti-depressants, neuroleptics, amifostine, baclofene : Co-administration of these drugs with eplerenone may potentially increase antihypertensive effects and risk of postural hypotension • Patients taking Cyclosporin or tacrolimus: Cyclosporin and tacromilus may lead to impaired renal function and increase the risk of hyperkalaemia. • Patients taking Trimethroprim: The concomitant administration of trimethroprim with eplerenone increases the risk of hyperkalaemia. • Patients taking Digoxin: Systemic exposure (AUC) to digoxin increases by 16% (90% CI: 4% - 30%) when co-administered with eplerenone. • Co-administration of St John's Wort (a strong CYP3A4 inducer) with eplerenone caused a 30 % decrease in eplerenone AUC. • Galactose intolerance or lactase deficiency (due to composition of tablet) • Systolic Blood pressure below 120mmHg
研究者
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