L-NMMA Dose-response Study in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01070940
First received: February 17, 2010
Last updated: February 18, 2011
Last verified: February 2011

February 17, 2010
February 18, 2011
February 2010
June 2010   (final data collection date for primary outcome measure)
Systolic blood pressure [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01070940 on ClinicalTrials.gov Archive Site
  • GFR [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Arterial Stiffness [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Fractional excretion of sodium [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Fractional excretion of potassium [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Plasma renin concentration [ Time Frame: 6 hour ] [ Designated as safety issue: No ]
  • Plasma angiotensin II [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Plasma aldosterone [ Time Frame: 6 hour ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01070940
EBP.FHC.1.2009, 2009-017001-11
Yes
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