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NCT01168908 · ClinicalTrials.gov registry record · Phase 2
Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
A Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01168908: Clinical Trial Phase 2 study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT01168908 is a Phase 2 study that was terminated before completion, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01168908, a Phase 2 study, was terminated before completion, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study, supported by Charley's Fund, Inc., is being done to determine if the drug Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks like the study drug, but contains no medication), improves heart function in people with Duchenne Muscular Dystrophy and Becker Muscular Dystrophy (DBMD). In people with DBMD, dystrophin is not present or lacking in heart and muscle. This is associated with abnormalities in an enzyme called "neuronal nitric oxide synthase" or nNOS, and leads to decreases in "cyclic GMP," which is necessary for proper function of those muscles. Revatio blocks an enzyme called phosphodiesterase 5 (PDE5), and helps to restore the normal amounts of cyclic GMP. The purpose of this research is to determine if Revatio is safe for people with DBMD and if it can improve heart function. Hypothesis : PDE5 inhibition, with the use of Revatio, will improve cardiac function in patients with DBMD.
Primary Outcome
To determine whether a 6 month trial of oral sildenafil compared to placebo improves cardiac contractile function in DBMD as determined by a \> 10% decline in end-systolic volume as detected by CMR.
Interventions
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
Why NCT01168908 stopped before completion
NCT01168908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Sildenafil is the first listed.
NCT01168908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01168908 about?
NCT01168908 is a clinical study titled "Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy". This study, supported by Charley's Fund, Inc., is being done to determine if the drug Revatio®(also known as Sildenafil), as compared to placebo (an inactive substance that looks like the study drug, but contains no medication), improves heart function in people with Duchenne Muscular Dystrophy and ...
What is the current status of trial NCT01168908?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01168908?
The interventions under investigation include: Sildenafil (DRUG).
Who is sponsoring clinical trial NCT01168908?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01168908's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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