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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01446003
Eligibility Criteria:
Inclusion Criteria:
* If female, must be of non-childbearing potential
* If male with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
* Body mass index (BMI) ≤35 kg/m\^2
* Mild-to-moderate hypertension requiring treatment with one or more antihypertensive agents
* Receiving stable treatment for hypertension for at least 8 weeks prior to the start of dosing and continuing therapy for duration of study
* No clinically significant arrhythmias or clinically significant abnormality on electrocardiogram
* Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Exclusion Criteria:
* Any illness that might confound the results of the study or poses an additional risk
* History of stroke, chronic seizures, or major neurological disorder
* Clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Clinically significant cardiovascular disease or has active angina
* History of malignant neoplastic disease
* Taking 325 mg aspirin daily
* Taking 3 or more medications for the treatment of hypertension
* Unable to refrain from or anticipates the use of any non-steroidal anti-inflammatory drugs (NSAIDs)
* Consumes excessive amounts of alcohol and/or coffee, tea, cola, or other caffeinated beverages
* Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
* Significant multiple and/or severe allergies
* Regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01446003
Study Brief:
Protocol Section:
NCT01446003