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NCT01865084 · ClinicalTrials.gov registry record · Phase 3
A Study of Tadalafil for Duchenne Muscular Dystrophy
A Phase 3 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
NCT01865084: Clinical Trial Phase 3 study, sponsored by Eli Lilly and Company.
NCT01865084 is a Phase 3 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 331 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01865084, a Phase 3 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
Study 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.
Primary Outcome
6MWD measured the distance in meters a participant was able to walk in 6 minutes. The study used 6MWD procedure modified specifically for use in boys with Duchenne muscular dystrophy (DMD), including standardized verbal encouragement at specific intervals to maintain attention to the test, and use of a "safety chaser" to walk behind the participant during testing (McDonald et al., 2010a). The LS mean (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM
Interventions
- DRUG Placebo
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
Why NCT01865084 stopped before completion
NCT01865084 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01865084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01865084 about?
NCT01865084 is a clinical study titled "A Study of Tadalafil for Duchenne Muscular Dystrophy". 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 rec...
What is the current status of trial NCT01865084?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2013-09. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01865084?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT01865084?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01865084's enrollment target sits among peer trials
331 1066th of 2000 higher than 935 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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