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临床试验/EUCTR2007-000762-20-SE
EUCTR2007-000762-20-SE进行中（未招募）不适用

A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of Galantamine + Sertraline, Galantamine or Sertraline in Obese Subjects

Theracos, Inc.0 个研究点目标入组 220 人开始时间: 2007年7月17日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
220
研究概览入排标准研究者记录与标识符相似试验

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. Age = 30 and = 60 years old
  • •2. Body mass index (BMI) is = 30 kg/m2 and = 40 kg/m2
  • •3. Completed at least 80% of the 7-day diet diary
  • •4. Women of childbearing potential with a negative pregnancy test prior to study entry and who agree to use an acceptable method of contraception throughout the study. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 with absence of menses for at least 12 months. In those subjects = 45 years an elevated serum FSH and the absence of menses for at least 12 months is required.
  • •5. Able to read and give written informed consent and have signed a consent form approved by the Investigator's Institutional Review Board (IRB) or Ethics Committee (EC)
  • •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

  • •1. Women who are pregnant or lactating
  • •2. Allergy to galantamine or sertraline or to any of the excipients
  • •3. Have lost more than 3 kg in the 3 months prior to the screening visit
  • •4. Current or previous use (within 3 months of randomization) of medications that influence weight
  • •5. Current or previous use (within 14 days of randomization) with a MAOI (e.g., phenelzine, tranylcypromine), pimozide or cholinesterase inhibitor drugs (e.g., donezepil, rivastigmine, tacrine), or SSRI drugs (e.g., citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline) or SNRI drugs (e.g., duloxetine, venlafaxine, buproprion), or tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline), or ergot drugs (e.g., ergotamine, dihydroergotamine, caffeine/ergotamine combinations, other combination drugs containing ergotamine) or triptans (e.g., sumatriptan, naratriptan, rizatriptan, almotriptan, zolmitriptan, eletriptan, frovatriptan)
  • •6. Current use of cimetidine, ketoconazole, warfarin
  • •7. Current history of atherosclerosis including cardiovascular disease (myorardial infarction, coronary artery bypass grafting, intracoronary stenting, percutaneous transluminal angioplasty or angina pectoris), peripheral vascular disease and cerebrovascular disease (including transient ischemic attack)
  • •8. Current acute or chronic liver disease, including acute hepatitis, chronic hepatitis, or cirrhosis; elevated total bilirubin > 1.5X ULN, elevated transaminases ALT and AST > 2X ULN or elevated GGT, or elevated alkaline phosphatase 2.5 x ULN
  • •9. Known endocrine origin for the subject's obesity, such as hypothyroidism and Cushing's syndrome
  • •10. Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
  • •11. Current serious/unstable medical condition including uncontrolled hypertension, active disease of the central nervous system such as seizure disorder, psychiatric illness (including major depression) or uncontrolled infection
  • •12. Current or history of abnormality of cardiac conduction, including first and second degree heart block
  • •13. History of mania/hypomania; history of suicide attempts or suicidal ideation or score indicative of major depression on a depression inventory test
  • •14. Major surgery in last 30 days or planned in next 6 months
  • •15. Current pharmacologically treated diabetes or fasting plasma glucose = 126 mg/dL
  • •16. Current active peptic ulcer disease or urinary outflow obstructive disorder and subjects at risk for urinary outflow obstruction such as those with clinecally significant benign prostatic hypertrophy or atonic bladder
  • •17. Current asthma or chronic obstructive pulmonary disease
  • •18. Current or history of renal disease or serum creatinine = 1.5 mg/dl
  • •19. Current or history (within the past year) of alcohol, drug or other substance abuse
  • •20. Participation in another experimental drug or device treatment protocol within the 30 days prior to screening or are scheduled to receive such a drug during the study period
  • •21. Subjects who are not willing or able to fully comply with the protocol
  • •22. Subjects whom the investigator believes to be medically unfit to receive the study treatment, or unsuitable for any other reason
  • •23. Subjects who have previously entered this study

研究者

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