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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
  Purpose
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.

Condition Intervention Phase
Healthy Drug: NG-monomethyl-L-arginine (L-NMMA) Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: L-NMMA's Effect on Renal and Cardiovascular Variables in Healthy Subjects. A Randomized, Placebo-controlled Crossover Study.

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 6 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Isotonic saline infusion Drug: Placebo
Isotonic saline solution IV priming dose + IV infusion for 1 hour
Active Comparator: Intravenous L-NMMA dose 2 Drug: NG-monomethyl-L-arginine (L-NMMA)
4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour
Active Comparator: Intravenous L-NMMA dose 3 Drug: NG-monomethyl-L-arginine (L-NMMA)
6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour
Active Comparator: Intravenous L-NMMA dose 1 Drug: NG-monomethyl-L-arginine (L-NMMA)
3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070940

Locations
Denmark
Departments of Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
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
  More Information

Responsible Party: Thomas Larsen, M.D., Departments of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT01070940     History of Changes
Other Study ID Numbers: EBP.FHC.1.2009
2009-017001-11 ( EudraCT Number )
Study First Received: February 17, 2010
Last Updated: February 18, 2011

Keywords provided by Regional Hospital Holstebro:
L-NMMA
blood pressure
arterial stiffness
pulse wave velocity
augmentation index
dose-response
healthy subjects
GFR

Additional relevant MeSH terms:
omega-N-Methylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017