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L-NMMA Dose-response Study in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070940
First Posted: February 18, 2010
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
February 17, 2010
February 18, 2010
February 21, 2011
February 2010
June 2010   (Final data collection date for primary outcome measure)
Systolic blood pressure [ Time Frame: 6 hours ]
Same as current
Complete list of historical versions of study NCT01070940 on ClinicalTrials.gov Archive Site
  • GFR [ Time Frame: 6 hours ]
  • Arterial Stiffness [ Time Frame: 6 hours ]
  • Fractional excretion of sodium [ Time Frame: 6 hours ]
  • Fractional excretion of potassium [ Time Frame: 6 hours ]
  • Plasma renin concentration [ Time Frame: 6 hour ]
  • Plasma angiotensin II [ Time Frame: 6 hours ]
  • Plasma aldosterone [ Time Frame: 6 hour ]
Same as current
Not Provided
Not Provided
 
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.
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Healthy
  • Drug: NG-monomethyl-L-arginine (L-NMMA)
    3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour
  • Drug: NG-monomethyl-L-arginine (L-NMMA)
    6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour
  • Drug: NG-monomethyl-L-arginine (L-NMMA)
    4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour
  • Drug: Placebo
    Isotonic saline solution IV priming dose + IV infusion for 1 hour
  • Placebo Comparator: Isotonic saline infusion
    Intervention: Drug: Placebo
  • Active Comparator: Intravenous L-NMMA dose 2
    Intervention: Drug: NG-monomethyl-L-arginine (L-NMMA)
  • Active Comparator: Intravenous L-NMMA dose 3
    Intervention: Drug: NG-monomethyl-L-arginine (L-NMMA)
  • Active Comparator: Intravenous L-NMMA dose 1
    Intervention: Drug: NG-monomethyl-L-arginine (L-NMMA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01070940
EBP.FHC.1.2009
2009-017001-11 ( EudraCT Number )
Yes
Not Provided
Not Provided
Thomas Larsen, M.D., Departments of Medical Research, Holstebro Hospital
Regional Hospital Holstebro
Not Provided
Principal Investigator: Thomas Larsen, M.D. Departments of Medical Research, Holstebro Hospital
Principal Investigator: Frank H Christensen, M.D. Departments of Medical Research, Holstebro Hospital
Principal Investigator: Erling B Pedersen, Dr.med. Departments of Medical Research, Holstebro Hospital
Principal Investigator: Jesper N Bech, Ph.d. Departments of Medical Research, Holstebro Hospital
Regional Hospital Holstebro
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP