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NCT01772758 · ClinicalTrials.gov registry record · Phase 2
Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
A Phase 2 study, sponsored by Augusta University.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01772758 is a Phase 2 study that has completed, run by Augusta University. The registered enrollment target is 64 participants.
The verdict
NCT01772758, a Phase 2 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients with CF, regardless of how healthy their lungs are. A critical barrier to improving the quality of life and longevity in patients with CF is our lack of knowledge regarding the different reasons why patients with CF cannot exercise to the level of their peers. We have collected preliminary data to support our central hypothesis that oxidative stress contributes to the impairment in blood vessel function at rest and during exercise which ultimately oxygen transport and delivery resulting in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this investigation represents a major breakthrough in the approach to begin understanding the physiological mechanisms which contribute to exercise intolerance in these patients.
Interventions
- DIETARY_SUPPLEMENT Antioxidant Cocktail
- DRUG BH4 5mg
- DRUG BH4 20mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-06-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01772758
The ClinicalTrials.gov registry entry for NCT01772758 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Antioxidant Cocktail is the first listed.
NCT01772758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01772758 about?
NCT01772758 is a clinical study titled "Cystic Fibrosis and Endothelial Function: At Rest and During Exercise". Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients with CF, regardless of how healthy their lungs are. A critical barrier...
What is the current status of trial NCT01772758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2011-08. Estimated completion is 2016-06-21.
What interventions are being tested in trial NCT01772758?
The interventions under investigation include: Antioxidant Cocktail (DIETARY_SUPPLEMENT), BH4 5mg (DRUG), BH4 20mg (DRUG).
Who is sponsoring clinical trial NCT01772758?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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