A phase III randomized, multicentre, double blind, active controlled trial to compare the efficacy and safety of two different anagrelide formulations in patients with essential thrombocythaemia - the TEAM-ET 2·0 trial.
Delayed-Action Preparations
Dose-Response Relationship, Drug
Double-Blind Method
Drug Compounding
Female
Humans
Male
Middle Aged
Platelet Aggregation Inhibitors
/ administration & dosage
Platelet Count
Quality of Life
Quinazolines
/ administration & dosage
Thrombocythemia, Essential
/ drug therapy
Treatment Outcome
anagrelide
essential thrombocythaemia
pharmacodynamics
pharmacokinetics
safety
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
25
09
2018
accepted:
18
12
2018
pubmed:
29
3
2019
medline:
2
5
2020
entrez:
29
3
2019
Statut:
ppublish
Résumé
Anagrelide is an established treatment option for essential thrombocythaemia (ET). A prolonged release formulation was developed with the aim of reducing dosing frequency and improving tolerability, without diminishing efficacy. This multicentre, randomized, double blind, active-controlled, non-inferiority trial investigated the efficacy, safety and tolerability of anagrelide prolonged release (A-PR) over a reference product in high-risk ET patients, either anagrelide-naïve or -experienced. In a 6 to 12-week titration period the individual dose for the consecutive 4-week maintenance period was identified. The primary endpoint was the mean platelet count during the maintenance period (3 consecutive measurements, day 0, 14, 28). Of 112 included patients 106 were randomized. The mean screening platelet counts were 822 × 10
Identifiants
pubmed: 30919941
doi: 10.1111/bjh.15824
pmc: PMC6594023
doi:
Substances chimiques
Delayed-Action Preparations
0
Platelet Aggregation Inhibitors
0
Quinazolines
0
anagrelide
K9X45X0051
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
691-700Informations de copyright
© 2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
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