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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT00592150
Eligibility Criteria:
Inclusion Criteria:
Normotensive (NT) Subjects
* Men and women between ages of 18 and 70 years (inclusive)
* BMI of 18-29 (inclusive).
* Healthy as determined by updated full medical history, physical exam and:
* Standard 12-lead EKG
* Complete blood count and differential
* Fasting blood chemistry (metabolic screen and liver enzymes), lipid panel (cholesterol, triglycerides, HDL and LDL cholesterol)
* Urinalysis with microscopy.
Hypertensive (HT) Subjects
* Men and women between ages of 18 and 70 years (inclusive)
* BMI of 18-29 (inclusive).
* Mild to moderate hypertension
* Established by prior diagnosis
* Or established with screening (sitting) diastolic blood pressure in the range of 90 to 114 mm
* Healthy as determined by updated full medical history and physical exam and:
* Standard 12-lead EKG
* Complete blood count and differential
* Fasting blood chemistry (metabolic screen and liver enzymes), lipid panel (cholesterol, triglycerides, HDL and LDL cholesterol)
* Urinalysis with microscopy.
Exclusion Criteria:
* Younger than 18; 71 and older
* History of malignant or accelerated hypertension
* Contraindication to discontinuing anti-hypertensive medications
* Currently taking clonidine
* Impaired renal function (serum creatinine \> 1.5 mg/dl) or urinary protein excretion \> 200 mg/day or continuing active urinary sediment
* Myocardial infarction, cerebrovascular accident or transient ischemic attack
* Congestive heart failure by history and physical examination, severe peripheral vascular disease
* Glaucoma as determined by the referring physician
* Pregnancy or nursing
* Failure to give informed consent or comply with the protocol
* Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 114 mm Hg (based on the mean of three consecutive measurements) following a three-week withdrawal of antihypertensive medications
* Protocol violations such as: failure to discontinue anti-hypertensive medications, failure to be admitted to the GCRC and complete failure to adhere to the prescribed diet.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00592150
Study Brief:
Protocol Section:
NCT00592150