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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT02485067
Eligibility Criteria:
Inclusion Criteria:
* 20 - 85 years
* History of OAB (pure urge or mixed urinary incontinence with predominant urge incontinence) for ≥ 6 months.
* In the case of females, at least 2 years has passed since menopause. Or all pre-menopausal female subjects must have been using a highly effective method of birth control during the study. Subject of childbearing potential must have had a negative pregnancy test prior to enrollment.
Exclusion Criteria:
* Predominate stress incontinence, insensate incontinence (those incapable of distinguishing discrete incontinence episodes) and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator.
* History of neurogenic bladder.
* PVR \> 200mL
* History of clinically significant renal disease or estimated creatinine clearance defined by Cockcroft and Gault formula \< 30 mL/min.
* History of malignant tumor within the past 5 years.
* History or presence of tachyarrhythmia or cardiac disease that in the opinion of the investigator might have confounded the results of the study or posed additional risk to the subject. Subjects who had a value for QTc \> 450 msec at the Screening visit.
* Patient with asthma
* PSA ≥ 10 ng/mL in male who is 50 years and over.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT02485067
Study Brief:
Protocol Section:
NCT02485067