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NCT02455336 · ClinicalTrials.gov registry record · Phase 2
Fenofibrate Treatment in SCI
A Phase 2 study of Spinal Cord Injury and Dyslipidemia, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 2
- Study locations
NCT02455336: Completed Phase 2 study of Spinal Cord Injury and Dyslipidemia, sponsored by VA Office of Research and Development.
NCT02455336 is a Phase 2 study of Spinal Cord Injury and Dyslipidemia that has completed, run by VA Office of Research and Development. The registered enrollment target is 23 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02455336, a Phase 2 study of Spinal Cord Injury and Dyslipidemia, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 2
- Study locations
Study Summary
Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emerges, which is characterized by low serum high density lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an independent risk factor for coronary artery disease, and elevations in serum triglycerides (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually similar to those of the general population. The current proposal in persons with SCI aims to determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid medication whose primary action lowers serum TG and raises serum HDL-C levels.
Primary Outcome
To determine the efficacy of fenofibrate monotherapy after 2 months of treatment to improve the lipoprotein profile; a successful response will be defined as a 25% reduction in the serum TG concentration at 2 months.
Conditions Studied
Interventions
- OTHER No intervention
- DRUG Fenofibrate
Study Locations (2)
New Jersey
- Kessler Institute for Rehabilitation - West Orange
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2018-08-01 |
| Phase | Phase 2 |
What the finished NCT02455336 record still lists
NCT02455336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which No intervention is the first listed.
NCT02455336 reports a single indexed study location in New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT02455336 about?
NCT02455336 is a clinical study titled "Fenofibrate Treatment in SCI". Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emer...
What is the current status of trial NCT02455336?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2015-05-18. Estimated completion is 2018-08-01.
What conditions does trial NCT02455336 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Dyslipidemia.
What interventions are being tested in trial NCT02455336?
The interventions under investigation include: No intervention (OTHER), Fenofibrate (DRUG).
Who is sponsoring clinical trial NCT02455336?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02455336 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02455336's enrollment target sits among peer trials
23 53rd of 99 higher than 47 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury 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.
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