CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Anagrelide +1 moredrug
Likely dose
Anagrelide 1.0 mg/day initial dose (titrated up by 0.5 mg/week as needed); Hydroxyurea 1000 mg/day initial doseAI-extracted
Key inclusion· 2
  • ✓Confirmed diagnosis of essential thrombocythaemia with high-risk profile
  • ✓No prior cytoreductive agent treatment
Key exclusion· 5
  • ✕Any other myeloproliferative disorder diagnosis
  • ✕Known secondary cause of thrombocytosis
  • ✕Current use of anticoagulant or antiplatelet therapies
  • ✕Known or suspected heart disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00202644
NCT00202644Phase 4Completed
CompareCT.gov

A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.

Shire·interventional·Posted Sep 20, 2005·Updated Jun 2, 2021

In Brief

A Phase 4 clinical trial evaluating Anagrelide and Hydroxyurea for Thrombocythemia, Hemorrhagic. Completed, enrolled 150 participants across 15 sites in 6 countries.

Detailed Summary

Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocythemia, Hemorrhagic
CountriesBulgaria, France, Hungary, Poland, Portugal, Serbia
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJan 13, 2006
Primary CompletionDec 15, 2015
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 20.8 years ago

Interventions

Anagrelidedrug

Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.

Hydroxyureadrug

Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.