Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.