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 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT01264692
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 18 to 75 years (inclusive) at screening.
* Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
* 12-lead ECG without clinically relevant abnormalities measured at screening.
* Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
* Signed informed consent in the local language prior to any study-mandated procedure
Exclusion Criteria:
* Mean SBP \> 180 mmHg.
* Severe, malignant, or secondary hypertension.
* Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
* E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
* Angina pectoris within 6 months prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01264692
Study Brief:
Protocol Section:
NCT01264692