A double-blind, placebo-controlled crossover trial to quantify the effects of sibutramine on energy intake and energy expenditure in obese subjects during a test meal - Sibutramine effects on energy balance in obesity

Aintree Hospitals NHS Trust and University of Liverpool0 个研究点目标入组 36 人开始时间: 2005年8月16日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1. Obesity with a body mass index (BMI)>30 kg/m2 and less than 40kg /m2
•2. Female, otherwise healthy
•3. Age 18-60
•4. Must be post-menopausal or sterilised or using a reliable form of 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

•1. Diabetes
•2. Use of other weight loss medication or any drug that might affect body weight or appetite (including anti-depressants, antipsychotics, beta-blockers, corticosteroids)
•3. Hyperthyroidism
•4. Hypothyroidism (subjects with a normal TSH and free T4, and on a stable dose of thyroxine for at least 3 months may be included)
•5. Uncontrolled hypertension (blood pressure >140/90 mmHg)
•6. History of ischaemic heart disease or stroke
•7. Significant cardiac dysrhythmias
•8. Known chronic liver disease
•9. Known renal failure
•10. Gilles de la Tourette syndrome
•11. Known phaeochromocytoma
•12. History of seizures or unexplained syncope
•13. Pregnancy
•14. History of intolerance to sibutramine or any of its constituents
•15. Recent major change in body weight (> 3kg loss or gain in preceding month)
•16. History of malignancy
•17. Presence of any other medical condition that would, in the opinion of the investigator preclude safe participation in the study

发起方

Aintree Hospitals NHS Trust and University of Liverpool