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ATLAS Therapy for Intermittent Claudication (ATLAS Trial)

Q: In what clinical contexts is L-Arginine regularly prescribed?

Pituitary dwarfism can be managed with L-Arginine, a supplement that also <a href="https://www.withpower.com/clinical-trials/aids">aids</a> in the relief of enzyme deficiencies, catarrh, and vitamin insufficiencies.

Q: Can new participants still join this clinical investigation?

Accurate. Per the information displayed on clinicaltrials.gov, this research is actively searching for volunteers to join their trial. The experiment was first posted in June 2021 and last modified in November 2022; it seeks 10 patients from a single site.

Q: How extensive is the sample size being utilized in this clinical experiment?

Affirmative. Clinicaltrials.gov reports that this trial was initially announced on June 15th 2021 and has been actively recruiting since then, with the most recent update being posted November 2nd 2022. This medical project requires 10 volunteers to be enrolled at a single site.

Q: Could you tell me if this experiment has been conducted before?

Since 2007, Baxter Healthcare Corporation has sponsored the first of 70 clinical trials for L-Arginine. This initial study involved 4640 participants and eventually led to its Phase 4 drug approval. Currently, these medical experiments are taking place in 277 cities across 36 countries worldwide.

Q: Has the FDA given its seal of approval to L-Arginine?

With limited evidence of its safety and efficacy, L-Arginine only managed to receive a score of 1.

Phase 1

Recruiting

Led By Louis M Messina, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years old

Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

ATLAS Trial Summary

This trial will focus on people with claudication, pain when walking due to peripheral arterial disease. They will test whether a therapy can increase production of Nitric Oxide, which may improve pain and physical activity.

Who is the study for?

Adults over 18 with claudication from peripheral arterial disease (PAD) can join this trial if they have an Ankle-Brachial Index (ABI) <0.9, agree to stop certain medications like Viagra and Cilostazol, and use contraception if sexually active. Excluded are those with severe blood pressure issues, recent heart attacks or strokes, critical leg ischemia, kidney/liver problems, history of seizures or stones in the kidney.Check my eligibility

What is being tested?

The study tests whether a combination therapy including Tetrahydrobiopterin at two different doses along with L-Ascorbate and L-Arginine can boost Nitric Oxide production in the blood. This could potentially improve walking distance without pain for those with PAD.See study design

What are the potential side effects?

Potential side effects may include changes in blood pressure or heart rate due to increased Nitric Oxide levels; gastrointestinal discomfort from L-Arginine; risk of kidney stones; and possible interactions leading to altered effectiveness of other medications.

ATLAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am willing to stop taking medications like Viagra or Cialis.

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My leg pain is moderate to severe when walking.

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I have poor blood flow in my legs as shown by specific tests.

Select...

I am willing to stop taking certain heart medications if required.

ATLAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nitric Oxide bioavailability

ATLAS Trial Design

2Treatment groups

Experimental Treatment

Group I: Tetrahydrobiopterin Dose 2 (Day 45 to 90)Experimental Treatment3 Interventions

All subjects will receive 3300mg l-Ascorbate, l-Arginine 3400mg and 20mg/kg of Tetrahydrobiopterin once a day.

Group II: Tetrahydrobiopterin Dose 1 (Day 0 to 44)Experimental Treatment3 Interventions

All subjects will receive 3300mg l-Ascorbate , l-Arginine 3400mg and 10mg/kg of Tetrahydrobiopterin once a day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Arginine

Not yet FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor

343 Previous Clinical Trials

986,600 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,017,053 Total Patients Enrolled

20 Trials studying Peripheral Arterial Disease

16,585 Patients Enrolled for Peripheral Arterial Disease

Louis MessinaLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what clinical contexts is L-Arginine regularly prescribed?

"Pituitary dwarfism can be managed with L-Arginine, a supplement that also aids in the relief of enzyme deficiencies, catarrh, and vitamin insufficiencies."

Answered by AI

Can new participants still join this clinical investigation?

"Accurate. Per the information displayed on clinicaltrials.gov, this research is actively searching for volunteers to join their trial. The experiment was first posted in June 2021 and last modified in November 2022; it seeks 10 patients from a single site."

Answered by AI

How extensive is the sample size being utilized in this clinical experiment?

"Affirmative. Clinicaltrials.gov reports that this trial was initially announced on June 15th 2021 and has been actively recruiting since then, with the most recent update being posted November 2nd 2022. This medical project requires 10 volunteers to be enrolled at a single site."

Answered by AI

Could you tell me if this experiment has been conducted before?

"Since 2007, Baxter Healthcare Corporation has sponsored the first of 70 clinical trials for L-Arginine. This initial study involved 4640 participants and eventually led to its Phase 4 drug approval. Currently, these medical experiments are taking place in 277 cities across 36 countries worldwide."

Answered by AI