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NCT04870229 · ClinicalTrials.gov registry record · Phase 2
Carnosine for Peripheral Arterial Disease
A Phase 2 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04870229: Completed Phase 2 study, sponsored by University of Louisville.
NCT04870229 is a Phase 2 study that has completed, run by University of Louisville. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04870229, a Phase 2 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The hypothesis is that oral supplementation of L-carnosine will inhibit PHDs, increase HIF1-translocation and angiogenesis and thus improve the functioning of lower extremities in PAD patients. Primary Aim: 1\. Compare the effect of carnosine and placebo supplementation on the 6MWT in PAD patients with and without claudication. Secondary Aim: 1. Determine whether carnosine supplementation improves the pain-free treadmill walking ability of the subjects supplemented with carnosine compared to placebo. 2. Compare the levels of carnosine, VEGF, HIF-1α, and PHDs activity in the skeletal muscle before and after placebo and carnosine supplementation. 3. Compare the levels of EPCs (CD34+/CD133+), inflammatory markers (serum amyloid A, hsCRP) and thrombotic markers (fibrinogen, homocysteine) as cardiovascular risk markers in these subjects. 4. Explore the effects of race and gender on VEG, carnosine, and HIF-1α levels in both groups.
Primary Outcome
Compare effects of carnosine and placebo supplementation on the 6MWT in patient with and without claudication
Interventions
- DRUG Placebo
- DRUG Carnosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-05-12 |
| Est. Completion | 2022-07 |
| Phase | Phase 2 |
What the finished NCT04870229 record still lists
NCT04870229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04870229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04870229 about?
NCT04870229 is a clinical study titled "Carnosine for Peripheral Arterial Disease". The hypothesis is that oral supplementation of L-carnosine will inhibit PHDs, increase HIF1-translocation and angiogenesis and thus improve the functioning of lower extremities in PAD patients. Primary Aim: 1\. Compare the effect of carnosine and placebo supplementation on the 6MWT in PAD patients...
What is the current status of trial NCT04870229?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2016-05-12. Estimated completion is 2022-07.
What interventions are being tested in trial NCT04870229?
The interventions under investigation include: Placebo (DRUG), Carnosine (DRUG).
Who is sponsoring clinical trial NCT04870229?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04870229's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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