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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00459056
Eligibility Criteria:
Inclusion Criteria:
* \>18 years old
* Systolic blood pressure (SBP) \>130 and/or diastolic blood pressure (DBP) \>85 (or currently taking anti-hypertensive medication)
* Waist circumference \>102 cm (men) and \>88 cm (women)
* Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study
Exclusion Criteria:
* Use of anti-hypertensive medications within one month of randomization (patients may be washed-out from anti-hypertensive medications)
* Unstable angina
* History of angina symptoms within 3 months of screening
* Decompensated heart failure
* History of myocardial infarction
* Stroke or coronary artery bypass graft within 3 months of screening
* Standard clinical contraindications to beta-blocker therapy
* Standard clinical contraindications to ACE-I therapy
* Women who are currently pregnant or planning to become pregnant (pregnancy testing will occur at specific intervals throughout study and women will be informed of potential risks during the consenting process; information specific to this risk will be detailed in the consent form)
* Breastfeeding women
* Clinically significant liver disease
* Creatinine \> 2.5 mg/dL
* Hepatic function greater than 3 times upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00459056
Study Brief:
Protocol Section:
NCT00459056