Status:
COMPLETED
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment
Lead Sponsor:
Imperial College London
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE4
Brief 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 volu...
Detailed Description
Primary Objective: To perform a systemic analysis of how COX-2 inhibition by celecoxib affects vascular function and 'omic biomarkers including those associated with the COX-2/prostacyclin/ADMA axis i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04765644
Start Date
June 10 2021
End Date
January 24 2022
Last Update
October 28 2024
Active Locations (1)
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1
Imperial College Clinical Research Facility
London, United Kingdom, w12 0HS