drugset / Trial / NCT01790997

Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

NCT01790997

Phase 3 Completed 126 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

Timeline

Start
2012-05
Primary completion
2013-11
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 80 mg
Comparator Clopidogrel Small molecule 75 mg
Subject DLBS1033 Protein / enzyme biologic 490 mg

Indications