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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02038868
Eligibility Criteria:
Inclusion Criteria:
* dysuria associated with BPH for at least 12 weeks before providing consent
* a total IPSS core of 13 or higher
* a QOL score of 3 or higher
* a maximum urinary flow rate (Qmax) of ≥4 mL/sec and \<15 mL/sec.
* a prostate volume of ≥20 mL.
Exclusion Criteria:
* A postvoid residual volume (PVR) of \>350 mL
* A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study
* A cataract operation scheduled to be performed during the study period
* Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study
* Hypersensitivity to ASP4901 or tamsulosin hydrochloride
* Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
74 Years
Study:
NCT02038868
Study Brief:
Protocol Section:
NCT02038868