Status:
COMPLETED
L-Arginine Metabolism in Essential Hypertension
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 dysfun...
Eligibility Criteria
Inclusion
- Males, ages 18-65
- Male and female healthy control subjects ages 18-65
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00137124
Start Date
May 1 2006
End Date
December 1 2009
Last Update
July 10 2012
Active Locations (1)
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1
CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Germany, 91054