CTRI/2019/11/021919进行中（未招募）3 期
A Phase III, Multi-Center, Comparative, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Cetilistat in Adult Obese Patients
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult male or female patients aged of 18-65 years
- •2. The patient with body mass index (BMI) =30 kg/m2
- •3. Females of childbearing potential who are sexually active must agree to use barrier contraceptives
- •4. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range
排除标准
- •1. Patients with known hypersensitivity to any of the components of the study drugs
- •2. Patients with significant weight loss in the 3 months prior to screening
- •3. Patients with history of any serious systemic disease
- •4. Changes in the dosing of antihyperlipidemic or anti-diabetic drugs within 4 weeks of randomization
- •5. Patients with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, before 4 weeks of screening
- •6. Patients with history of anaphylaxis associated with medicinal products
- •7. History of drug or alcohol abuse within the past 2 years
- •8. Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization
- •9. Any other serious disease or condition at screening (or randomization) that would compromise patient safety
- •10. Patients with the current/past infections such as tuberculosis, hepatitis, herpes and/or patients with immune system disorders like HIV and SLE
研究者
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