NCT01865084

A Study of Tadalafil for Duchenne Muscular Dystrophy

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Muscular Dystrophy, Duchenne

Interventions

Type	Name	Description
DRUG	Tadalafil	Administered orally
DRUG	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2013-05-30
• Last updated: 2019-10-09
• Results posted: 2017-03-01

Locations

62 sites across 16 countries: United States, Argentina, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Puerto Rico, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom