EUCTR2006-002951-33-ES进行中（未招募）1 期
A 12-month multicentre, randomised, double-blind, placebo-controlled study with two parallel groups to assess the effects of rimonabant 20 mg in patients with abdominal obesity and microalbuminuria, with type 2 diabetes mellitus or dyslipidaemia with or without other cardiometabolic risk factors. - RIALTO
sanofi-aventis, S.A.0 个研究点目标入组 550 人开始时间: 2015年1月27日最近更新:
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
- 550
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
- •1. Men or women aged ? 30 years and < 75 years.
- •2. BMI > 27 kg/m2 and < 40 kg/m2.
- •3. Willingness and ability to comply with the study protocol.
- •4. Written informed consent at the time of enrolment into the study.
- •5. Waist circumference > 102 cm in men and > 88 cm in women.
- •6. Microalbuminuria ? 20 mg/g creatinine and < 300 mg/g creatinine in at least
- •two of three morning urine samples taken on 3 separate days prior to the
- •baseline visit.
- •7. Type 2 diabetes and/or dyslipidaemia.
- •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 550
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Breastfeeding or pregnant women or who expect to become pregnant.
- •2. Non-use of approved methods of contraception in women of child-bearing
- •3. History of very low calorie diet in the 3 months prior to the screening visit
- •(<1200 kcal/day).
- •4. Change in weight > 5 kg in the 3 months prior to the screening visit.
- •5. History of surgery for weight loss (such as vertical banded gastroplasty,
- •gastric by-pass, etc.)
- •6. History of bulimia or anorexia nervosa according to DSM-IV definition.
- •7. Any clinically significant endocrine disorder, in the opinion of the
- •investigator, especially known alterations in the blood concentration of TSH
- •and free T4.
研究者
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