Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment (NCT04765644) | Clinical Trial Compass
CompletedPhase 4
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment
United Kingdom44 participantsStarted 2021-06-10
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<50 bpm
* Sitting systolic blood pressure \<80 or \>160 mmHg
* Sitting diastolic pressure \<60 or \>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