跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/SLCTR/2018/009
SLCTR/2018/009终止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

Dr Shohini Ghosh0 个研究点开始时间: 待定最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
3 期
状态
终止
发起方
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

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 hours’ 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 mmHg and DBP >110 mmHg based on 24 hours 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 SGLT2 inhibitors
  • •6.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.

研究者

发起方
Dr Shohini Ghosh

相似试验

已完成
3 期
To evaluate the efficacy and safety of TRC150094 as an Add On to Standard of Care in Improving Cardiovascular Risk in Subjects with Diabetes, Dyslipidemia and Hypertensio
CTRI/2017/11/010555Torrent Pharmaceutical Ltd986
已完成
3 期
A Phase III, Clinical Trial to Evaluate the safety, tolerability and efficacy of 2 Fixed dose combinations of Azelnidipine and Chlorthalidone when compared with fixed dose combination of Amlodipine and Hydrochlorothiazide in patients with Stage II hypertension.
CTRI/2020/03/023708Synokem Pharmaceuticals Ltd210
进行中（未招募）
1 期
A study to assess effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) in patients having acute respiratory distress syndrome (ARDS)
EUCTR2014-005260-15-CZFaron Pharmaceuticals Ltd300
进行中（未招募）
1 期
A study to assess effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) in patients having acute respiratory distress syndrome (ARDS)Adult patients diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS)MedDRA version: 20.0 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855
EUCTR2014-005260-15-DEFaron Pharmaceuticals Ltd296
进行中（未招募）
1 期
A study to assess effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) in patients having acute respiratory distress syndrome (ARDS)
EUCTR2014-005260-15-ESFaron Pharmaceuticals Ltd300