NCT02078908|CompletedPhase 1DMC
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
12
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)The purpose of this study is to investigate the effect of different doses of sodium nitrite infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated. Hypothesis Sodium nitrite infusion
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 19, 2013
Actual (reported)March 5, 2014
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)Fractional urinary sodium excretion
One day
Nitrite clearance
One day
Nitrate clearance
One day
Glomerular filtration rate
One day
Proximal sodium transport
One day
Free water clearance
One day
Continuous 2 hour infusion of sodium nitrite, 40 micrograms/kg/hour
Continuous 2 hour infusion of sodium nitrite, 120 micrograms/kg/hour
Continuous 2 hour infusion of sodium nitrite, 240 micrograms/kg/hour
Continuous 2 hour infusion of sodium nitrite, 40 micrograms/kg/hour
Continuous 2 hour infusion of sodium nitrite, 120 micrograms/kg/hour
Department of Medical Research, Regional Hospital Holstebro
Holstebro, 7500, Denmark
Jesper N Bech, MD, PhD
Regional Hospital Holstebro
12 participants (actual enrollment reported by the registry).
First Submitted
September 19, 2013
First Posted
March 5, 2014
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Hypertensive Versus Healthy Subjects
Continuous 2 hour infusion of sodium chloride, 25 ml/hour
Continuous 2 hour infusion of sodium nitrite, 240 micrograms/kg/hour
Continuous 2 hour infusion of sodium chloride, 25 ml/hour
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
October 9, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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