EUCTR2007-001787-71-DE进行中（未招募）不适用
The influence of Rimonabant induced cannabinoid receptor blocking on the mass and function of the left ventricle in patients with abdominal adiposity - ADIPOHEART
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •abdominal adiposity (waist circumference >102 cm men, >88 cm women)
- •blood pressure <140/90 mm Hg
- •age 18-60 years
- •possibility to discontinue concomitant medication during treatment with the study
- •women of childbearing potential with 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •body mass index <28 or >40 kg/m2
- •weight >130kg
- •increase in body weight >2 kg in the run-in phase
- •changes in body weight >2 kg within 3 month prior to study start; history of
- •surgical reduction of body weight
- •Diabetes mellitus Type 1 or 2
- •familiar alterations of metabolism
- •hepatic disease, Cholestase (transaminases or gamma-GT increased more than 2-
- •symptomatic or detected coronary heart disease, myocardial infarct
- •heart insufficiency NYHA II-IV
- •symptomatic/detected valvular defect
- •symptomatic or detected peripheral arterial occlusive disease
- •atherosclerosis der hirnversorgenden Arterien, TIA or apoplexia
- •renal insufficiency or serum creatinine above the normal range
- •sleep apnoea
- •coagulation disorder or intake of oral anticoagulants
- •contraindication to do cardiac MRTs: pacemaker or other metal implantations, atrial
- •fibrillation
- •disease or operation effecting drug resorption
- •pregnancy or breastfeeding
- •autoimmune disease; organ transplantation; History of malignancy and chronic
- •history of alcohol or drug abuse, or both; psychiatric disorder
- •history of treated or untreated depressive phases
- •intake of antidepressants or drugs to reduce the body weight during the last year prior to study start
- •Participation in another investigational drug trial within the eight weeks prior to study entry
- •incompatibility to Rimonabant or ingredients of the study drug
- •incompatibility to Lidocain
- •patients with epilepsy or anamnestischen Krampfanfällen
- •patients with hereditary galactose intolerance, lactase deficiency or glucose-
- •galactose malabsorption
研究者
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