Submitted by: Jamie Anne Y. Lee 2018-01-08 00:00:00 Last Updated by: Quintiles 2018-10-23 14:44:42 Export to PDF

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

PHRR180109-001745

CT/P015/CMR/16/03_01

2017-CT0426

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

This is a phase III randomized, double Blind, Parallel Group, placebo controlled 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. 
 
TRC150094 is an experimental drug which reduces blood sugar, blood cholesterol and blood pressure by correcting the underlying defect in metabolism (all the chemical processes in the body, especially those that cause food to be used for energy and growth) of cholesterol and sugars in the body. Animal studies as well as phase I and phase II clinical trials in subjects have shown improvement in blood pressure, cholesterol and blood sugar. Further safety and efficacy of the experimental treatment is being studied in a larger population in this study. 
 
It is anticipated that 1250 subjects will take part in this study. The primary purpose of this study is to evaluate the efficacy of TRC150094 when given in addition to the treatment that may already be receiving, in reducing high blood sugar (diabetes), high cholesterol (dyslipidemia) and high blood pressure (hypertension) which increase the chances of suffering from complications like heart attack, stroke and heart failure (cardiovascular risk) associated with these in future. Another purpose of the study is to evaluate safety of TRC150094 in subjects with high blood sugar (diabetes), high cholesterol (dyslipidemia) and high blood pressure (hypertension).
 
The study consists of screening period, treatment period, safety extension period and post treatment follow up period and post completion treatment period. Subjects will be randomized to receive either TRC150094 45 mg tablet, once daily or matching placebo for 24 weeks. Subjects completing 24 weeks of main study will be rolled over to safety extension phase of 26 weeks. However, subjects in safety phase will be required to stop study treatment and those in the main study will not be rolled over to the safety extension phase once last enrolled subject completes 12 weeks of main study treatment. In safety extension phase, subjects will continue to receive either test product - TRC150094 45 mg tablet once daily or matching placebo according to their initial randomization in the study. All subjects will undergo follow up visit, 4 weeks post completion of treatment period. The subjects who are in the main study, will not be rolled over to the safety extension phase but shall complete total 24 weeks of treatment period.
 
Ambulatory Blood Pressure Monitoring (ABPM) will be done at screening/baseline visit, at week 12 and week 24. Blood Samples are collected for the laboratory tests that includes: Hematology, biochemistry, Serological tests (At screening visit only), Lipid parameters and glycemic parameters. Urine samples are collected for the laboratory tests that includes: urinalysis, urine pregnancy test (female).
 
Independent Data Safety and Monitoring Board (DSMB) will evaluate all safety related data at regular interval during the study.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-08-02 36 2021-08-02 0000-00-00

Ongoing

Institution Classification Region LTO #
Torrent Pharmaceuticals Limited Private Business India Not Applicable
Institution Classification Region LTO #
Quintiles Philippines, Inc. Private Business NCR CDRR-NCR-CRO-2
Institution Amount Region
Torrent Pharmaceuticals Limited N/A India
Name E-Mail Phone Number Postal Address
Elena Lam QMNL.HealthRegistrymailbox@quintiles.com 6328783179 7A, 7F 8 Rockwell Bldg., Hidalgo Drive, Rockwell Center, Makati City
Name E-Mail Phone Number Postal Address
Dr. Evangeline Costelo Evangeline.Costelo@quintiles.com 639175124337 7A, 7F 8 Rockwell Bldg., Hidalgo Drive, Rockwell Center, Makati City
Name Expertise Affiliation
Ma. Dovie Lallaine Ygpuara, MD Endocrinology/Diabetes St. Paul's Hospital Iloilo
Olivia Piores-Roderos, MD Endocrinology/Diabetes/Metab De La Salle Health Sciences Institute
Clodoaido Caringal, MD Endocrinology/Diabetes/Metab Philippine Heart Center
Grace P. Aquitania, MD Endocrinology/Diabetes/Metab Davao Doctors Hospital
Florence M. Amorado-Santos, MD Endocrinology Mary Mediatrix Medical Center
Gabriel B. Jocson III, MD Internal Medicine and Cardiology Angeles University Foundation Medical Center
Project Location Institutional Ethics Review Board
St. Paul's Hospital Iloilo St. Paul’s Hospital Iloilo – Institutional Ethics Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Philippine Heart Center Philippine Heart Center Ethics Review Committee
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
Mary Mediatrix Medical Center Mary Mediatrix Medical Center Institutional Ethics Review Board
Angeles University Foundation Medical Center Angeles University Foundation Medical Center Institutional Ethics Review Committee

High blood sugar (diabetes), high cholesterol (dyslipidemia) and high blood pressure (hypertension) which increase your chances of suffering from complications like heart attack, stroke and heart failure (cardiovascular risk) associated with these in future.

To evaluate the efficacy of TRC150094 in improving cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension

2. To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension
3. To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in subjects with diabetes, dyslipidemia and hypertension

Recruiting

  • Brazil
  • India
  • Philippines
  • Sri Lanka
  • Thailand

Clinical Trial

20170904151728

2017-12-15

Date Amendment Classification Reason
2018-03-07 Amendments related to the protocol
2018-04-24 Amendments related to the protocol

• 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. Systolic Blood Pressure (SBP) ≥140 mmHg and Diastolic Blood Pressure (DBP) ≥ 90 mmHg 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.
 
• Exclusion Criteria
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
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.

Interventional

TRC150094

TRC150094 is an experimental drug which reduces blood sugar, blood cholesterol and blood pressure by correcting the underlying defect in metabolism (all the chemical processes in the body, especially those that cause food to be used for energy and growth) of cholesterol and sugars in the body. Animal studies as well as phase I and phase II clinical trials in subjects have shown improvement in blood pressure, cholesterol and blood sugar. Further safety and efficacy of the experimental treatment is being studied in a larger population in this study.                                                    After successful completion of screening all eligible subjects will be randomized (1:1) and receive one of the two treatments either test product – TRC150094 45 mg tablet or matching placebo in a double blind manner. Each subject will receive test product – TRC150094 45 mg tablet or placebo once a day for 24 weeks. Subjects completing 24 weeks’ treatment will enter a safety extension phase and their study drugs will be continued as per initial randomization. Drug compliance will be assessed by physical verification of study drugs. Compliance, of <80% would be considered as ‘non-compliant’ during statistical analysis. Subjects will be asked to bring all trial medication containers (with or without any remaining tablets) with them to each trial visit.

Randomized

Double Blind

This will be a double-blind study design. The subjects and investigator (and other personnel involved in the study) will be unaware of the study drugs administered to individual subjects. The Sponsor will remain blind during the study. The placebo tablets will be identical in appearance and taste to that of TRC150094 tablets. At regular monitoring visits, a study monitor will ensure that the blind is maintained and all code-break envelopes remain intact. All study personal involved in the conduct and management of the study will remain blinded throughout the conduct of study.

Parallel

The primary purpose of this study is to evaluate the efficacy of TRC150094 when given in addition to the treatment subject may already receiving, in reducing high blood sugar (diabetes), high cholesterol (dyslipidemia) and high blood pressure (hypertension) which increase thechances of suffering from complications like heart attack, stroke and heart failure (cardiovascular risk ) associated with these in future.

Phase III

14

Unspecified

Unspecified

02 Aug 2018

Utilization Utilization Info
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