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A Study of Tadalafil for Duchenne Muscular Dystrophy

NCT01865084 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2019-10-09

Study results available
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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

DRUG

Tadalafil

Administered orally

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865084 on ClinicalTrials.gov