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Completed

NCT Number: NCT01070940

L-NMMA Dose-response Study in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Departments of Medical Research

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NG-monomethyl-L-arginine (L-NMMA)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Systolic blood pressure

    Time frame: 6 hours

Secondary outcomes

  1. GFR

    Time frame: 6 hours

  2. Arterial Stiffness

    Time frame: 6 hours

  3. Fractional excretion of sodium

    Time frame: 6 hours

  4. Fractional excretion of potassium

    Time frame: 6 hours

  5. Plasma renin concentration

    Time frame: 6 hour

  6. Plasma angiotensin II

    Time frame: 6 hours

  7. Plasma aldosterone

    Time frame: 6 hour

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2010
Registry last updated
Feb 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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