Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: TRC150094: TRC150094 45 mg is taken orally, swallowed as a whole with water preferably in the morning under fasting conditions.
Control Intervention1: Matching Placebo: Placebo taken or
Sponsors
Torrent Pharmaceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms Mean change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms Timepoint: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in MAP from baseline to 24 weeks of treatment Mean change in non-HDL cholesterol from baseline to 24 weeks of treatment Mean change in HbA1c from baseline to 24 weeks of treatmentTimepoint: Week 24 | — |
Countries
Brazil, India, Philippines
Contacts
Public ContactDr Amarinder Singh
Torrent Pharmaceuticals Ltd
Outcome results
None listed