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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01114360
Eligibility Criteria:
Inclusion Criteria:
* Males or females ages 18 to 64
* Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) \>115 mmHg))
* Taking no more than 2 antihypertensive medications
* African-American race (self-defined by the participant)
Exclusion Criteria:
* Secondary forms of hypertension
* Presence of other diseases requiring treatment with BP lowering medications
* Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and transient ischemic attacks)
* Diabetes mellitus (type 1 or 2)
* Cancer/Malignancy other than nonmelanoma skin cancer
* Primary renal disease
* Serum creatinine \> 1.5 mg/dL in men or \> 1.4mg/dL in women
* Severe anemia
* Liver enzymes \> 2.5 times upper limits of normal
* Hepatitis B, Hepatitis C, or HIV positive as assessed by questionnaire
* Current treatment with or regular use of calcium channel blocking agents, cyclooxygenase-2 or COX2-inhibitors, oral contraceptives, estrogen, sildenafil, vardenafil, tadalafil, antidepressants, corticosteroids, or warfarin
* Current use of melatonin or any sleep aids containing melatonin.
* Regular consumption (1 or more times per week) of any of the following of Vitamin methyl B12, St. Johns Wort, Feverfew, black and white mustard seeds, wolf berry seed
* Severe Sleep apnea
* Night work
* Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01114360
Study Brief:
Protocol Section:
NCT01114360