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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 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.
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.
Interventions
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01168908
The ClinicalTrials.gov registry entry for NCT01168908 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sildenafil is the first listed.
NCT01168908 reports 0 study locations.
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.
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