EUCTR2008-001840-38-NL进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Female Subjects - BET207
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- OBEcure Ltd.
- 入组人数
- 180
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
- Female
入选标准
- •- Signed written informed consent;
- •- Female subjects 18 to 50 years of age;
- •- Pre-menopause;
- •- Obese with a BMI > or = 30 kg/m2 to < or = 40 kg/m2;
- •- Has been obese for at least one year prior to screening;
- •- Non-lactating & Non-pregnant
- •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
- •- Has obesity of known endocrine origin (e.g., Cushing’s disease, Addison’s disease, hypothalamic tumor), genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome);
- •- Previous surgical procedures for weight loss;
- •- History of bulimia or evidence of laxative abuse;
- •- Active or past history of cardiovascular or cerebrovascular disease
- •- Type 1 diabetes mellitus;
- •- Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c >8%;
- •- Renal insufficiency defined as a serum creatinine > or = 1.5 mg/dL (133 µmol/L) at screening;
- •- History of asthma, peptic ulcers or HIV;
- •- Chronic use of antihistamines;
研究者
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