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Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia

NCT01214915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-06-09

Study results available
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Summary

The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.

Conditions

  • Essential Thrombocythemia (ET)

Interventions

DRUG

Anagrelide Hydrochloride

Subjects will be started at 1.0 mg per day and titrated as necessary.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-27
Primary Completion
2012-10-24
Completion
2012-10-24

Countries

  • Japan

Study Locations

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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 NCT01214915 on ClinicalTrials.gov