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Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT00344916
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : July 11, 2006
Sponsor:
Information provided by:
Regional Hospital Holstebro

June 24, 2006
June 27, 2006
July 11, 2006
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Complete list of historical versions of study NCT00344916 on ClinicalTrials.gov Archive Site
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Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis
NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones
Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.

In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on:

  • renal hemodynamics (GFR and RPF)
  • blood pressure and heart rate
  • lithium clearance
  • plasma levels of vasoactive hormones
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Liver Cirrhosis
Drug: Ng-monomethyl-L-arginine (drug)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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Inclusion Criteria:

Healthy controls

  • Age 20 to 60 years
  • Both men and women
  • Weight below 100 kg
  • Normal clinical examination and laboratory screening
  • Fertile women only if using contraception
  • Informed consent according to the regulations of the local ethics committee

Liver cirrhosis

  • Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites
  • P-creatinine < 250 µmol/L
  • Age 20-60 years
  • Both men and women
  • Fertile women only if using contraception
  • Body weight below 100 kg
  • Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

  • History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
  • Current medication
  • Drugs or alcohol abuse
  • Pregnancy
  • Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
  • Donation of blood less than 1 month before the experiments

Liver cirrhosis

  • Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
  • Drugs or alcohol abuse
  • Pregnancy
  • Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00344916
MED.RES.HOS.1996.04.JNB
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Regional Hospital Holstebro
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Study Chair: Erling B Pedersen, Professor Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Principal Investigator: Jesper N Bech, MD, Ph.d. Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Regional Hospital Holstebro
June 2006

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