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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00891267
Eligibility Criteria:
Inclusion Criteria:
* Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
* Blood pressure greater than or equal to 130/85 mmHg AND
* hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
* abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
* triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
* fasting blood glucose greater than or equal to 110mg/dL
Exclusion Criteria:
* Insulin depended diabetes or type-1 diabetes
* Severe or resistant hypertension
* Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
* Any acute or chronic inflammatory disease
* Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
* Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00891267
Study Brief:
Protocol Section:
NCT00891267