CTRI/2013/03/003445已完成2 期
Safety and efficacy of TRC150094 in treatment of cardio-metabolic risk in overweight/obese pre-diabetic subjects with dyslipidemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
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
- •Male and female subjects in the age range 30-65 (both inclusive) years
- •Waist circumference in men >=90 cm and women >=80 cm
- •BMI in the range 23-35 (inclusive) kg/m2
- •ApoB >= 100 mg/dl
- •Triglyceride >=150mg/dl
- •Fasting Blood Glucose >= 100 mg/dl
- •Serum Insulin >= 12 µU/ml
- •Blood pressure: SBP >=130 mmHg and DBP >=85 mmHg with/ without anti-hypertensive treatment
排除标准
- •SBP/DBP >=160/100 mmHg.
- •Subjects on Insulin therapy
- •Subjects having FPG 126 mg/dl or HbA1C 6.4 or on antidiabetic medication
- •Serum Triglycerides 400 mg/dL
- •LDL-Cholesterol 300 mg/dl or Medical History/clinical evidence of Familial Hyperlipidemic Disorder.
- •Subjects on anti-hyperlipidemic agents other than statins
- •History of angina, Myocardial Infarction (MI) or stroke within 6 months of screening
- •ALT or AST >= ULN 3 times
- •Alcohol intake (ethanol) 20 ml/day which is equivalent to 40 ml whisky/rum/gin/vodka/hard liquors or 240 ml of beer, or 90 ml of wine per day (averaged for 7 days).
- •eGFR 30 mL/min as evaluated by Cockroft-Gault method
- •Subjects having thyroid dysfunction (TSH 0.3 or 5.0) or euthyroid on thyroid medication or hormone related obesity disorder
- •Seropositive for HIV, Hepatitis B, Hepatitis C
- •Pregnant or lactating females.
- •History of Drug abuse
- •History of psychiatric disorder
- •History of any bleeding disorder
- •History of malignancy in last 3 years
- •Women of child bearing potential on Hormonal contraceptives for the duration of the study.
- •Clinically relevant abnormal physical or laboratory findings at the screening examination as judged by the investigator, which would interfere with the objectives of the study.
- •Intake of any investigational drug within 3 months prior to first dose of study drug.
- •History of significant blood loss due to any reason, including blood donation, in the 12 weeks prior to the first dose of study drug; or the total blood loss in the last 3 months, including for this study, exceeds 450 ml
研究者
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