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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT00452192
Eligibility Criteria:
Inclusion Criteria:
1. Male subject of 18 to 65 years of age
2. Subjects with at least 3 of 5 criteria of the metabolic syndrome:
* Central (abdominal) obesity: waist circumference \>= 102 cm
* Hypertension: \>=135/\>=85 mmHg
* Hypertriglyceridemia: \>= 150 mg/dL
* Low HDL -cholesterol: \< 40 mg/dL
* Hyperglycemia: fasting glucose \>= 110 mg/dL and
3. Subjects with a history of essential hypertension or newly diagnosed with essential hypertension with a BP reaching following criteria:
* MSSBP \>=135 mmHg and \< 180 mmHg and/or MSDBP \>= 85 mmHg and \< 110 mmHg
4. Subjects who are eligible, able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them. Existence of written informed consent.
5. Subjects with normal renal function (according to the MDRD IV eGFR \> 60 ml/min/1.73m\^2)
Exclusion Criteria:
1. Subjects treated with an ACE or an ARB within 3 month of study entry who are unable or unwilling to undergo the 3 month washout period.
2. Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).
3. Any of the following conditions: Atrial fibrillation, AV block II or higher, history of myocardial infarction, instable angina pectoris, pathologic ECG changes, heart failure NYHA III/IV
4. Severe Depression
5. History of epileptic seizures
6. Proliferative Retinopathy
7. MSSBP pressure \> 180 mmHg or MSDBP \> 110 mmHg
8. Known Renal arterial stenoses (on one or both sides)
9. Known or suspected contraindications or intolerance to or history of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (e.g., ARBs) as the study drug.
10. Subjects who take drugs that are not approved/admitted in germany or subjects participating now or three month prior to this trial in other studies.
11. Therapy with not allowed concomitant drugs.
12. Current abuse or recent history of alcohol or other drug substance abuse (past 12 month).
13. Subjects that in the eye of the investigation seem to be noncompliant and unwilling or not able to show up for control examinations. Subjects with a history of non-compliance to medical regimes or unwillingness to comply with the study protocol.
14. Subjects whose body structure (e.g., weight, height, body circumference, etc.) exceeds the restrictions of the local site of MRI instrument.
15. Use of pacemakers, ICD, defibrillators, or any device which interferes with an MRI. Subjects that have any metallic material anywhere in their body that might interfere with an MRI.
16. Significant claustrophobia.
17. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
* History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
* Currently active or previously active inflammatory bowel disease during the 12 months prior to study entry.
* Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to study entry.
* Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
* Evidence of hepatic disease as determined by any one of the following:
* SGOT
* or GPT values exceeding \> 150 % of the upper limit of the normal range GGT
* or AP or bilirubin levels exceeding 200 % of the upper limit of the normal range.
* Evidence of renal impairment as determined by anyone of the following:
* serum creatinine \> 1.7 mg/dl for males and serum creatinine of \> 1.5 mg/dl for females at study entry
* a history of dialysis, or
* a history of nephritic syndrome.
* Current treatment with cholestyramine and colestipol resins.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00452192
Study Brief:
Protocol Section:
NCT00452192