EUCTR2009-010116-15-DE进行中（未招募）不适用
A multicentre double blind placebo controlled clinical dose- finding study for three doses of Antiadipositum X 112 T® (Cathine-hydrochloride) vs. placebo in 240 patients with a body mass index (BMI) between 27 kg/m2 and 40 kg/m2 - X 112 dose-finidng
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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 and female patients, aged 18-65 years
- •caucasian origin
- •diet-related obesity diagnosed by BMI of 30 to 40 kg/m² or diet-related obesity diagnosed by BMI of 27 to 40 kg/m² in patient with coexisting risk factors like hyperlipidaemia, type 2 diabetes mellitus
- •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
- •organic reasons for obesity, e.g. hypothyroidism
- •severe eating disorder
- •clinically significant cardiac, neuropsychiatric or endocrine disorder
- •Gilles-de-la-Tourette-Syndrom
- •unstable coronary heart disease, heart insufficiency, tachycardia, peripheral artery occlusive disease, hearth rhythm disturbances, angina pectoris, cerebrovascular diseases
- •severe arterial and pulmonary hypertension
- •Cushing’s syndrome
- •impaired liver function
- •impaired kidney function
- •men: prostate hypertrophy
- •phaeochromocytoma
- •diseases which lead to an increase in intraocular pressure
- •haemorrhagic diathesis
- •other severe systemic concomitant diseases (except type 2 diabetes mellitus, hyperlipidaemia)
- •intake of drugs which increase blood pressure and heart rate e.g drugs against cough, cold and allergies like ephedrine and pseudoephedrine and drugs with a decongestant effect like xylometazoline.
- •application of adrenergic amines, concurrent or less than two weeks back application of monoaminooxidase inhibitor (MAO-inhibitor), amantadine as well as central nervous system effective drugs for the treatment of mental diseases (e.g. antidepressants, neuroleptics) or drugs for weight reduction or tryptophane for the treatment of insomnia
- •intake of guanethidine.
- •intake of neuroleptics like phenothiazine and butyrophenone.
- •known intolerance to Cahine , or other ingredients of the test/reference drug
- •high caffeine consumption (6 and more cups coffee/day)
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to assess efficacy and safety of Alvalin® (active agent) vs. placebo (inactive substance) in 265 obese patients/group with a body mass index (BMI) between 30 and 45 kg/m2. Neither the investigator nor the participant are aware of the nature of the treatment the participant is receiving. The trial is conducted in several trial centres.diet-related obesity diagnosed by BMI of 30 to 45 kg/m²EUCTR2012-003426-24-DERiemser Pharma GmbH
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/ASecondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-NLBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-EEBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/ASecondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-LTBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-GBBioMS Technology Corp553