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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT01244035
Eligibility Criteria:
Inclusion Criteria:
* Participant has essential hypertension who is in grade 1 or 2 hypertension according to the European Society of Hypertension (ESH) as delineated in the European Society of Cardiology (ESC) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.
* Otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator
* Participant is generally in good health with the exception of hypertension
* Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months
Exclusion Criteria:
* Participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study
* Participant has a history of stroke, chronic seizures, or major neurological disorder
* Participant has a disability that can interfere with rising from a semi-recumbent position to the standing position
* Participant has a personal or family history of a bleeding or clotting disorder
* Participant has a history of frequent nosebleeds or recurrent or active gingivitis
* Participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study
* Participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage
* Participant is categorized as class II or greater according to the New York Heart Association (NYHA) functional classification for heart failure
* Participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as St. John's Wort) during the study
* Participant anticipates using phosphodiesterase (PDE5) inhibitors \[sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®)\] during the study
* Participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)
* Participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study
* Participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT01244035
Study Brief:
Protocol Section:
NCT01244035