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L-Arginine Metabolism in Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00137124
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
Essential hypertension is characterized by impaired endothelial function. Data derived from normotensive subjects with a genetic predisposition to arterial hypertension suggest that endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in the L-arginine/NO pathway can be postulated. The investigators at the University of Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension is associated with alterations in L-arginine metabolism and transport. This study will determine whether metabolism and transport of L-arginine are altered in patients with essential hypertension and whether these potential alterations can be targeted therapeutically.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: L-Arginine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension
Study Start Date : May 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: L-Arginine
    oral administration of L-arginine for 4 weeks


Primary Outcome Measures :
  1. meaning of L-arginine transport and metabolism on endothelial function [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males, ages 18-65
  • Male and female healthy control subjects ages 18-65

Exclusion Criteria:

  • Any other coexisting condition
  • Advanced damage of vital organs (grade III und IV retinopathy)
  • Therapy with a not approved concomitant medication in the last 4 weeks prior to intake of the first trial medication, especially lipid lowering and antidiabetic medications (washout phase)
  • Blood donation within the last 4 weeks
  • Patients with arterial fibrillation or atrioventricular (AV)-block (II and more)
  • Patients with anamnestic myocardial infarct
  • Patients with depression
  • Patients with seizure disorders
  • Patients with unstable angina pectoris including electrocardiogram (ECG)-aberrations or cardiac insufficiency New York Heart Association (NYHA) Stadium III and IV
  • History of a malignant illness with the exception of those patients who have recovered for more than 10 years or have a basalioma of the skin.
  • Actual or anamnestic alcohol or drug abuse
  • History of organ transplant
  • Anaphylaxis or known therapy resistance to any of the used test matters.
  • Therapy with a not approved concomitant therapy
  • Participation in another study within three months prior to study inclusion
  • Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance
  • Liver or kidney diseases: SGOT, GPT , γ-GT, AP, bilirubin and creatinine above 200% of standard
  • Patients who are not sufficiently compliant; or patients who are not capable or willing to appear for controlling visits.
  • Severe or unstable medical or psychiatric illnesses, which will, in the estimation of the examiner, endanger the safety of the proband or the successful participation in the study
  • Presumed risk of transmission of HIV or hepatitis via blood from the proband

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137124


Locations
Germany
CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Markus P Schlaich, MD CRC, Medizinische Klinik 4 - Nephrology and Hypertension

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00137124     History of Changes
Other Study ID Numbers: KFO 106 TP8
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by University of Erlangen-Nürnberg Medical School:
Essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases