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L-NMMA Dose-response Study in Healthy Subjects

L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01070940
Enrollment
12
Registered
2010-02-18
Start date
2010-02-28
Completion date
2010-06-30
Last updated
2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

L-NMMA, blood pressure, arterial stiffness, pulse wave velocity, augmentation index, dose-response, healthy subjects, GFR

Brief summary

The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.

Interventions

3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour

DRUGPlacebo

Isotonic saline solution IV priming dose + IV infusion for 1 hour

Sponsors

Regional Hospital Holstebro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy males * Age 18-35 years * BMI 18.5-30.0

Exclusion criteria

* Tobacco or illicit drug use * Current use of any prescription or non-prescription drugs * Alcohol abuse * History of heart failure, lever failure, chronic kidney disease or cerebral insult * Diabetes * Clinical or paraclinical signs of infection * Pathologic ECG * Ambulatory blood pressure \>140/90 mmHg * Abnormal blood or urin screening tests

Design outcomes

Primary

MeasureTime frame
Systolic blood pressure6 hours

Secondary

MeasureTime frame
Arterial Stiffness6 hours
Fractional excretion of sodium6 hours
Fractional excretion of potassium6 hours
GFR6 hours
Plasma angiotensin II6 hours
Plasma aldosterone6 hour
Plasma renin concentration6 hour

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026