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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT01104558
Eligibility Criteria:
Inclusion Criteria:
* \>18 years of age and \<80 years of age
* Chronic heart failure subjects with stable clinical condition
* New York Heart Association (NYHA) functional classification II-III
* Left ventricular ejection fraction (LVEF) ≤45%
Exclusion Criteria:
* NYHA functional classification IV
* Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
* Hypersensitivity to bisoprolol or any of the Concor excipients
* Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
* Systolic Blood Pressure \<90 millimeters of mercury (mmHg) at screening
* Resting Heart Rate \<55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at screening
* Subjects who are taking concomitant drug which can have drug-drug interaction (DDI) with bisoprolol
* Woman of childbearing age without effective contraception measures, or who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01104558
Study Brief:
Protocol Section:
NCT01104558