Benign Prostate Hyperplasia
Conditions
Keywords
ASP4901, BPH
Brief summary
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.
Detailed description
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).
Interventions
DRUGASP4901
oral
DRUGTamsulosin
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total IPSS (International Prostate Symptom Score) | baseline and at the final evaluation (up to 5 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in each symptom score of IPSS | baseline and at the final evaluation (up to 5 weeks) | — |
| Change from baseline in IPSS QOL (quality of life) score | baseline and at the final evaluation (up to 5 weeks) | — |
| Proportion of IPSS responder | baseline and at the final evaluation (up to 5 weeks) | IPSS responder is defined as 25% improvement in IPSS |
| Plasma concentration of ASP4901 | up to 5 weeks | only for ASP4901 group |
| Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs | up to 5 weeks | — |
Countries
Japan
Outcome results
None listed