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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT00627861
Eligibility Criteria:
Inclusion Criteria:
Twenty subjects with a history of hypertension with the following inclusion criteria will be enrolled:
* Age 18-80 years
* Stage 1 (systolic 140-159 mm Hg or diastolic 90-99 mmHg) or Stage 2 (systolic \>160 mm Hg or diastolic \>100 mmHg) or current treatment with antihypertensive medication.
* PRA ≥0.65 ng/ml/h. If PRA is below this level during the screening period, due to treatment with a beta-blocker or central α2-receptor agonist, the subject may be enrolled and the PRA level re-checked after treatment is tapered off.
Exclusion Criteria:
* History of diabetes requiring pharmacologic treatment with an oral or parenteral hypoglycemic agent, including insulin
* TIA, stroke or myocardial infarction
* History of asthma or COPD
* Cockcroft Gault estimated GFR \<60 ml/min/1.73 m2
* Previous adverse events during treatment with a β-blocker or aliskiren
* ALT level twice normal
* Secondary forms of hypertension (e.g., renovascular, primary aldosteronism)
* PRA\<0.65 ng/ml/h after discontinuation of antihypertensive medication
* Systolic BP\>180 mm Hg, diastolic BP\>105 mm Hg
* Pregnant or breastfeeding, or planning pregnancy during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00627861
Study Brief:
Protocol Section:
NCT00627861