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 Hypertension

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/11/010555
• Date of registration: 17-11-2017
• Prospective Registration: Yes
• Primary sponsor: Torrent Pharmaceutical Ltd
• Public title: 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 Hypertension
• Scientific title: 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
• Date of first enrolment: 02-04-2018
• Target sample size: 1035
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19913
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Brazil, India, Philippines

Contacts

• Name: Dr Amarinder Singh
• Affiliation: Torrent Pharmaceuticals Ltd

• Name: Dr Amarinder Singh
• Affiliation: Torrent Pharmaceuticals Ltd

Key inclusion & exclusion 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 <=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


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 <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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: I509- Heart failure, unspecified

Intervention(s)

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 orally, swallowed as a whole with water preferably in the morning under fasting conditions.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

CT/P015/CMR/16/03_01 Version no: 1.1 Dated: 15/11/2017

Source(s) of Monetary Support

Torrent Pharmaceuticals Ltd, Torrent Research Centre Village: Bhat Gandhinagar, Gujarat,India

Ethics review

Status: Approved
Approval date: 23/04/2018
Contact:

S R Kalla Memorial Ethical Committee for Human Research

Status: Approved
Approval date: 05/09/2018
Contact:

Institutional Ethics Committee, Endolife Speciality Hospitals Private Limited

Status: Approved
Approval date: 05/10/2018
Contact:

Yalamanchi Hospitals And Research Centres Pvt Ltd Ethics Committee

Status: Approved
Approval date: 03/01/2019
Contact:

Life Care Hospital Institutional Review Boaed

Status: Approved
Approval date: 23/04/2019
Contact:

Institutional Ethics Committee- Clinical Studies

Status: Approved
Approval date: 25/04/2019
Contact:

BMCRI Ethics Committee Bangalore Medical College and Research Institute

Status: Approved
Approval date: 27/04/2019
Contact:

Popular Hospital Ethics Committee

Status: Approved
Approval date: 27/04/2019
Contact:

RuddrakshaHospitalEthics Committee bareja

Status: Approved
Approval date: 28/04/2019
Contact:

KRM Hospital Ethics Committee

Status: Approved
Approval date: 29/04/2019
Contact:

Vijaya Ethics Committee

Status: Approved
Approval date: 30/04/2019
Contact:

HCG Multi Speciality Ethics Committee, HCG Hospitals,

Status: Approved
Approval date: 02/05/2019
Contact:

Institutional Ethics Committee of Kovai Diabetes Speciality Centre and Hospital Coimbatore Tamilnadu

Status: Approved
Approval date: 05/05/2019
Contact:

Ashirwad Ethics Committee

Status: Approved
Approval date: 06/05/2019
Contact:

Surakshaka Institutional Ethics Committee

Status: Approved
Approval date: 07/05/2019
Contact:

Aster Aaadhar Ethics Committee kolhapur

Status: Approved
Approval date: 09/05/2019
Contact:

Suraksha Ethics Committee

Status: Approved
Approval date: 10/05/2019
Contact:

Institutional Ethics Committee Grant Goverment Medial College and Sir JJ Group of Hospitals

Status: Approved
Approval date: 11/05/2019
Contact:

Ethics Committe of Sunils Diabetes Care n Research Centre

Status: Approved
Approval date: 14/05/2019
Contact:

Human Welfare Ethical Committee for Human Sciences and Research

Status: Approved
Approval date: 14/05/2019
Contact:

Institutional Ethics Committee, Lisie Hospital Kochi

Status: Approved
Approval date: 15/05/2019
Contact:

Ethics Committee SP Medical College and AG Hospitals rajasthan

Status: Approved
Approval date: 17/05/2019
Contact:

Magna Care Ethics Committee

Status: Approved
Approval date: 17/05/2019
Contact:

Shivam Ethics Committee

Status: Approved
Approval date: 20/05/2019
Contact:

BAPS Pramukh Swami Hospital Institutional ethics Committee

Status: Approved
Approval date: 23/05/2019
Contact:

Department of Pharmacology, MGM campus, MGM Medical College and Hospital,

Status: Approved
Approval date: 24/05/2019
Contact:

Institutional Ethics Committee, Dr.Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre

Status: Approved
Approval date: 26/05/2019
Contact:

Ethics Committee Brij Medical Centre Kanpur UP

Status: Approved
Approval date: 27/05/2019
Contact:

Pentamed Ethics Committee

Status: Approved
Approval date: 29/05/2019
Contact:

Institutional Ethic, research Committee, Aster, medcity, kochi

Status: Approved
Approval date: 31/05/2019
Contact:

Dr.Ram Manohar Lohia Institute of Medical Sciences Ethics CommitteeLucknow

Status: Approved
Approval date: 31/05/2019
Contact:

Institutional Ethics Committee, Room No-306-A, Maulana Azad Medical College

Status: Approved
Approval date: 03/06/2019
Contact:

Institutional Ethics Committee, G.S.V.M Medical College

Status: Approved
Approval date: 10/06/2019
Contact:

LPR Ethics Committee, Life point Multispecialty Hospital pune

Status: Approved
Approval date: 14/06/2019
Contact:

Institutional Ethics Committee, Indian Institute of Diabetes

Status: Approved
Approval date: 15/06/2019
Contact:

Medisys Clinisearch Ethical Review Board

Status: Approved
Approval date: 21/06/2019
Contact:

Ethics committee CIMETs Inamdar hospital

Status: Approved
Approval date: 21/06/2019
Contact:

Institutional Ethics Committee for Human Research, Medical College and SSG

Status: Approved
Approval date: 24/06/2019
Contact:

ILS Hospital Ethics Committee kolkatta

Status: Approved
Approval date: 29/06/2019
Contact:

Institutional Ethics Committee, Thumbay Hospital

Status: Approved
Approval date: 03/07/2019
Contact:

Institutional Ethics Committee KAHER JNMC Campus Nehrunagar Belagavi

Status: Approved
Approval date: 07/07/2019
Contact:

Institutional Ethics committee, Government Medical college, Kozikode

Status: Approved
Approval date: 10/07/2019
Contact:

Supe Hospital Ethics Committee

Status: Approved
Approval date: 24/07/2019
Contact:

DEW and Trinity Institutional NagpurEthics Committee

Status: Approved
Approval date: 31/07/2019
Contact:

Ethics Committee Sanjeevan Hospital

Status: Approved
Approval date: 11/09/2019
Contact:

Holy Family Hospital Ethical Committee

Status: Approved
Approval date: 21/09/2019
Contact:

Ethics Committee, Prof.M.Vishwanathan Diabetes Research Centre

Status: Approved
Approval date: 12/10/2019
Contact:

Institutional Ethics Committee-IMS and SUM Hospital Odisha

Status: Approved
Approval date: 13/11/2019
Contact:

Drug Trial Ethics Committee ludhiana Punjab

Results

• Date Completed: 14/04/2021