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:
NCT01602367
Eligibility Criteria:
Inclusion Criteria:
* Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic
* Mean 24-hour diastolic blood pressure ≥85 mmHg
* Body mass index (BMI) ≥27 kg/m2
* If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks
Exclusion Criteria:
* History of Cushing's disease or syndrome, or Addison's disease
* Glycosylated hemoglobin (HbA1c) ≥10%
* Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months
* History of impaired renal or hepatic function
* BMI ≥50 kg/m2
* Any injectable antihyperglycemic agent (such as insulin) within 16 weeks
* Currently receiving more than one class of antihypertensive agents within 4 weeks
* Daily use of nonsteroidal anti-inflammatory agents within 1 week
* Use of androgen medications, including topical preparations, within 6 weeks
* Diagnosis or history of breast cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01602367
Study Brief:
Protocol Section:
NCT01602367