drugset / Trial / NCT01972477

DLBS1449 in Diabetic Patients With Low HDL

NCT01972477 ↗

Phase 2/3 Withdrawn Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in elevating high density lipoprotein (HDL) cholesterol in diabetic patients. The hypothesis of interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level from baseline to the end of study significantly higher than the elevation resulted by placebo. In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide a significantly better response than that of the lower dose (DLBS1449 75 mg daily).

Timeline

Start
2016-07
Primary completion
2017-10
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS1449 Unknown 75 mg —
Subject DLBS1449 Unknown 150 mg —