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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)
ノバルティスファーマ株式会社(INDUSTRY)