A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.
Condition or disease
Benign Prostate Hyperplasia
Drug: ASP4901Drug: TamsulosinDrug: Placebo
This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).
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Ages Eligible for Study:
40 Years to 74 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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