CTRI/2017/11/010555已完成3 期
A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add On to Standard of Care in Improving Cardiovascular Risk in Subjects with Diabetes, Dyslipidemia and Hypertension
Torrent Pharmaceutical Ltd0 个研究点目标入组 986 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 986
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.Male and female subjects in the age range 30-70 years (both inclusive)
- •2.BMI in the range 23-39 (inclusive) kg/m2
- •3.HbA1C >=7.5 %
- •4.Stable therapy of <=2 oral hypoglycemic agents for at least two months prior to screening at doses that are appropriate for the duration of the study in the judgment of the investigator.
- •5.Non HDL-cholesterol >= 160 mg/dL.
- •6.Mean Arterial Pressure (MAP) >=100 mm Hg based on average of 24 hoursâ??ambulatory blood pressure monitoring with or without anti-hypertensive treatment (subjects will have to be on stable dose of anti-hypertensive treatment for at least two months prior to screening); Dose should be appropriate for the
- •duration of the study in the judgment of the investigator.
- •7.Willing to give written informed consent
- •8.Ability to adhere to the study restrictions and assessments schedule
排除标准
- •1.Uncontrolled hypertension: SBP of >= 180 mm Hg and DBP >= 110 mmHg based on average of 24 hoursâ?? ambulatory blood pressure monitoring.
- •2.HbA1C > 10 % at screening.
- •3.Serum triglycerides >400 mg/dL.
- •4.LDL-cholesterol >300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
- •5.Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
- •6.Acute coronary syndrome (ACS) or stroke or any revascularization within last 6 months.
- •7.Subjects having untreated thyroid dysfunction (TSH <0.3 or >5.5 μIU/mL) or hormone related obesity disorder.
- •8.Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value.
- •9.eGFR <30 mL/min as evaluated by MDRD method
- •10.Seropositive for HIV, Hepatitis B or Hepatitis C.
- •11.History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years.
- •12.Pregnant or lactating women.
- •13.Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device).
- •14.Male subjects with partners of childbearing potential not willing to use reliable contraception methods.
- •15.Clinically significant abnormal physical findings, laboratory results, ECG findings and/or any other clinical observation or history during the screening examination, which would interfere with the objectives of the study.
- •16.Intake of any investigational drug within 3 months prior to the first dose of study drug.
- •17.In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or plan to relocate during the study.
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