Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT02783456
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02783456
Study Brief:
Protocol Section:
NCT02783456