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NCT04800692 · ClinicalTrials.gov registry record · Phase 1
The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication
A Phase 1 study of Peripheral Artery Disease and Peripheral Vascular Diseases, sponsored by Louis Messina.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04800692: Recruiting Phase 1 study of Peripheral Artery Disease and Peripheral Vascular Diseases, sponsored by Louis Messina.
NCT04800692 is a Phase 1 study of Peripheral Artery Disease and Peripheral Vascular Diseases that is actively recruiting participants, run by Louis Messina. The registered enrollment target is 10 participants, below the 127-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04800692, a Phase 1 study of Peripheral Artery Disease and Peripheral Vascular Diseases, is actively recruiting participants, sponsored by Louis Messina.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will focus on people with claudication from peripheral arterial disease. The investigators are researching whether a multicomponent therapeutic can increase the production of Nitric Oxide in the blood and whether that leads to an improvement in pain free walking distance and overall physical activity.
Primary Outcome
Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD).
Conditions Studied
Interventions
- DRUG Tetrahydrobiopterin 10 mg/kg
- DRUG Tetrahydrobiopterin 20 mg/kg
- DRUG L-Ascorbate
- DRUG L-Arginine
Study Locations (1)
Massachusetts
- UMASS Memorial Healthcare - University Campus - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-06-15 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT04800692 shows while recruiting
NCT04800692 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 127-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 4 interventions - of which Tetrahydrobiopterin 10 mg/kg is the first listed.
NCT04800692 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04800692 about?
NCT04800692 is a clinical study titled "The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication". This study will focus on people with claudication from peripheral arterial disease. The investigators are researching whether a multicomponent therapeutic can increase the production of Nitric Oxide in the blood and whether that leads to an improvement in pain free walking distance and overall physi...
What is the current status of trial NCT04800692?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-06-15. Estimated completion is 2027-12.
What conditions does trial NCT04800692 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, Peripheral Vascular Diseases, Claudication, Intermittent.
What interventions are being tested in trial NCT04800692?
The interventions under investigation include: Tetrahydrobiopterin 10 mg/kg (DRUG), Tetrahydrobiopterin 20 mg/kg (DRUG), L-Ascorbate (DRUG), L-Arginine (DRUG).
Who is sponsoring clinical trial NCT04800692?
This trial is sponsored by Louis Messina, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04800692 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04800692's enrollment target sits among peer trials
10 48th of 50 higher than 3 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease 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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