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L-Arginine Metabolism in Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
L-Arginine
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg

Outcomes

Primary Outcome Measures

meaning of L-arginine transport and metabolism on endothelial function

Secondary Outcome Measures

Full Information

First Posted
August 26, 2005
Last Updated
July 6, 2012
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00137124
Brief Title
L-Arginine Metabolism in Essential Hypertension
Official Title
Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-Arginine
Intervention Description
oral administration of L-arginine for 4 weeks
Primary Outcome Measure Information:
Title
meaning of L-arginine transport and metabolism on endothelial function
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus P Schlaich, MD
Organizational Affiliation
CRC, Medizinische Klinik 4 - Nephrology and Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

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L-Arginine Metabolism in Essential Hypertension

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