Phase
Condition
Williams Syndrome
High Blood Pressure (Hypertension - Pediatric)
Diabetes And Hypertension
Treatment
N/AClinical Study ID
Ages 18-50 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with mild-moderate arterial hypertension (grade 1-2)
Informed consent in writing available
Willing and able to comply with all requirements of the study
Male, between 18 and 50 years (inclusive)
Body Mass Index (BMI) 18-27 kg/m2
Non-smoker
Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis).
Minor deviations of laboratory values, ECG, and vital sign parameters from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
Additional inclusion criteria for the cohort with arterial hypertension:
- uncomplicated arterial hypertension WHO grade 1-2, office blood pressure 140-179/90-109 mmHg
Exclusion Criteria for healthy individuals:
Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
eGFR < 60 ml/min/1,73m2 or kidney stones
Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
Office blood pressure at screening higher than 140/100 mmHg
Office heart rate at screening outside the range of 50-99 beats per minute (inclusive).
Regular intake of medication within 1 month prior to study inclusion
Participation in any other clinical study within 30 days prior to inclusion in this study.
Clinically significant diseases (as judged by the investigator) within four weeks prior to screening
History of alcohol or drug abuse.
Exclusion criteria for patients with arterial hypertension:
Regular intake of medication within 1 month prior to study inclusion
office blood pressure at screening visit > 180/110 mmHg
secondary hypertension application of
antihypertensive medication within 14 days prior to study inclusion
of "other" medication
Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgement).
S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
eGFR < 60 ml/min/1,73m2 or kidney stones
Clinically significant history of cardiovascular disease or any known present cardiovascular disease other than arterial hypertension.
History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders, other than arterial hypertension.
Office heart rate at screening outside the range of 50-99 beats per minute (inclusive).
Regular intake of medication within 1 month prior to study inclusion
Participation in any other clinical study within 30 days prior to inclusion in this study.
Clinically significant diseases (as judged by the investigator) within four weeks prior to screening, other than arterial hypertension.
History of alcohol or drug abuse.
Study Design
Study Description
Connect with a study center
University of Erlangen-Nuremberg
Erlangen, Bavaria 91054
GermanySite Not Available

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