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Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

NCT01790997 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2014-06-04

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

DLBS1033

1 tablet of DLBS1033 490 mg thrice daily, after meal

DRUG

Aspirin

1 tablet of aspirin 80 mg once daily, after meal

DRUG

Clopidogrel

1 tablet of clopidogrel 75 mg once daily, after meal

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Ismail Setyopranoto, dr., SpS(K) · Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

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 NCT01790997 on ClinicalTrials.gov