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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01865084
Study type Interventional
Source Eli Lilly and Company
Contact
Status Terminated
Phase Phase 3
Start date September 2013
Completion date March 2016

See also
  Status Clinical Trial Phase
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Completed NCT03127241 - User-centred Assistive System for Arm Functions in Neuromuscular Subjects N/A
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Terminated NCT03400852 - A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy Phase 2