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クッシング病患者の治療におけるLCI699の安全性と有効性

基本情報

NCT ID
NCT02180217
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
137
治験依頼者名
Novartis

概要

The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU. This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.

対象疾患

Cushings Disease

介入

osilodrostat(DRUG)
LCI699 matching placebo(DRUG)

依頼者(Sponsor)