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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 is a Phase 3 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 331 participants.
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.
Interventions
- DRUG Placebo
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01865084
The ClinicalTrials.gov registry entry for NCT01865084 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01865084 reports 0 study locations.
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.
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