デュシェンヌ型筋ジストロフィーに対するタダラフィルの研究

基本情報

NCT ID

NCT01865084

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

331

治験依頼者名

Eli Lilly and Company

概要

The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

対象疾患

介入

依頼者（Sponsor）