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Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension

NCT03254446 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2020-07-17

No results posted yet for this study

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-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

Conditions

Interventions

DRUG

TRC150094

TRC150094 Tablet 45 mg

DRUG

Placebo

Matching Placebo Tablet

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Nikhil Tandon, M.D., PhD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2022-04-30
Completion
2022-08-31

Countries

  • Brazil
  • India
  • Philippines

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254446 on ClinicalTrials.gov