Status:
UNKNOWN
Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
Lead Sponsor:
Torrent Pharmaceuticals Limited
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Diabetes
Dyslipidemias
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
Brief Summary
The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-...
Detailed Description
TRC150094 is an Investigational Product for the treatment of CV risk associated with non-traditional risk factors ie, diabetes, hypertension and dyslipidemia, which acts by increasing the energy expen...
Eligibility Criteria
Inclusion
- Male and female subjects in the age range 30-70 years (both inclusive)
- BMI in the range 23-39 (inclusive) kg/m2
- HbA1C ≥7.5 %
- 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.
- Non HDL-cholesterol ≥ 160 mg/dL.
- Mean Arterial Pressure (MAP) ≥100 mm Hg based on average of 24 hours' ambulatory blood pressure monitoring (ABPM) with or without antihypertensive 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.
- Willing to give written informed consent
- Ability to adhere to the study restrictions and assessments schedule
Exclusion
- Uncontrolled hypertension: SBP of ≥ 180 mm Hg and DBP ≥ 110 mmHg based on average of 24 hours' ambulatory blood pressure monitoring.
- HbA1C \> 10 % at screening.
- Serum triglycerides \>400 mg/dL.
- LDL-cholesterol \>300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
- Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
- Acute coronary syndrome (ACS) or stroke or any revascularization within last 6 months.
- Subjects having untreated thyroid dysfunction (TSH \<0.3 or \>5.5 µIU/mL) or hormone related obesity disorder.
- Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value.
- eGFR \<30 mL/min as evaluated by Modification of Diet in Renal Disease (MDRD) method.
- Seropositive for HIV, Hepatitis B or Hepatitis C.
- History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years.
- Pregnant or lactating women.
- Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device).
- Male subjects with partners of childbearing potential not willing to use reliable contraception methods.
- 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.
- Intake of any investigational drug within 3 months prior to the first dose of study drug.
- 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.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT03254446
Start Date
March 12 2018
End Date
August 1 2022
Last Update
July 17 2020
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Comitê de ética em Pesquisa do Hospital Pró Cardíaco
Rio de Janeiro, Botafogo, Brazil, 22270-005
2
Avenida Angélica
São Paulo, CEP, Brazil, 01228-200
3
Rua Silva Jardim
São Bernardo do Campo, São Paulo, Brazil, 09715-090 -
4
Av. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS
Canoas, Brazil