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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT00330369
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are competent to provide written consent
* Aged 35 to 80 years
* Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
* All other subjects must have a mean systolic blood pressure ≥140 mmHg
* Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
* Female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
Exclusion Criteria:
* Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
* Serum ALT or AST \>2 x the upper limit of the normal range (ULN)
* Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
* Implanted pacemakers or implanted cardioverter defibrillator (ICD)
* Symptomatic congestive heart failure requiring treatment
* Hemodynamically significant valvular heart disease
* Type I diabetes mellitus
* Hemodialysis or peritoneal dialysis; or history of renal transplant
* Diagnosis or recurrence of malignancy within the past 3 years
* Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
* Subjects who perform alternating shift or night work
* Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT00330369
Study Brief:
Protocol Section:
NCT00330369