NCT01070940|CompletedPhase 1DMC
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.
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
12
1 country
1
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 17, 2010
Actual (reported)February 18, 2010
Actual (reported)June 2010
Actual (reported)June 2010
Actual (reported)Systolic blood pressure
6 hours
GFR
6 hours
Arterial Stiffness
6 hours
Fractional excretion of sodium
6 hours
Fractional excretion of potassium
6 hours
Plasma renin concentration
6 hour
3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour
6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour
Departments of Medical Research
Holstebro, Holstebro, 7500, Denmark
Thomas Larsen, M.D.
Departments of Medical Research, Holstebro Hospital
Frank H Christensen, M.D.
Departments of Medical Research, Holstebro Hospital
Erling B Pedersen, Dr.med.
Departments of Medical Research, Holstebro Hospital
Jesper N Bech, Ph.d.
Departments of Medical Research, Holstebro Hospital
12 participants (actual enrollment reported by the registry).
First Submitted
February 17, 2010
First Posted
February 18, 2010
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour
Isotonic saline solution IV priming dose + IV infusion for 1 hour
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
February 21, 2011
Record last verified: 2011-02
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Source: ClinicalTrials.gov.
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