冠動脈疾患を有する2型糖尿病患者におけるコルヒチンの用量探索試験

基本情報

NCT ID

NCT03376698

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

54

治験依頼者名

University of the Ryukyus

概要

This study is designed to investigate dose-dependent effects of low dose colchicine on inflammatory responses, endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activation. This study also tested the relationship between doses and safety issue such as incidence of diarrhea. Eligible patients will be randomly allocated to three treatment group: colchicine at 0.5mg per day, 0.25mg per day or placebo for 12 weeks in a double blind , parallel group design. High sensitive-CRP at 4 weeks as primary end point and flow mediated vasodilatation at 12 weeks as the secondary end point will be measured.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)