Phase 4 Completed N=44 Randomized Quadruple-blind Basic Science

Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment

Healthy

Source: ClinicalTrials.gov NCT04765644 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcomePrimary: Log Reactive Hyperaemic Index — 0.003; 0.095 LnRHI (Log Reactive hyperaemic index)

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

A single centre, placebo controlled, blinded (participant, investigator, outcome assessor) trial to evaluate the effects of COX-2 inhibition with celecoxib on endothelial function in healthy male volunteers.

Outcome Measures

Outcome	Result	p-value
PRIMARY Log Reactive Hyperaemic Index	0.003; 0.095	—
PRIMARY Augmentation Index	3.7; -2.54	—
SECONDARY Blood Pressure	-1.45; 2.03	—
SECONDARY Increase/Decrease of Cardiovascular Biomarkers From Baseline	0; 0	—

Eligibility Criteria

Inclusion Criteria

No abnormal findings on medical history, screening physical examination, hematology, biochemistry, urinalysis (including specific gravity), and vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) within 2 weeks of commencement of the study.
Normal fasting lipid profile
Non-smoking
Clear venous access in upper limbs
BMI: 18-30
No history or signs of drug abuse
No other medication 4 weeks before or during the study
Informed written consent

Exclusion Criteria

Any history of allergy to NSAIDS or arginine
Significant medical conditions
Pulse rate 160 mmHg
Sitting diastolic pressure 100 mmHg
Baseline endothelial dysfunction (as defined by EndoPAT; LnRHI <0.51)
Participation in other clinical study 8 weeks before or during the study
Donation of blood 8 weeks before or during the study
Those on medication that cannot be discontinued

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04765644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.