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Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

NCT00540423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-03-30

Study results available
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Summary

This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

Conditions

  • Chronic Idiopathic Thrombocytopenic Purpura
  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

SB-497115-GR 12.5mg

SB-497115-GR 12.5mg tablet once a day

DRUG

SB-497115-GR 25mg

SB-497115-GR 25mg tablet once a day

DRUG

SB-497115-GR 12.5mg matching placebo

SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day

DRUG

SB-497115-GR 50 mg

SB-497115-GR 25mg tablet x2 once a day

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

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 NCT00540423 on ClinicalTrials.gov