Clinical trial NCT02038868: A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
Official title: Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostate Hyperplasia
Keywords: ASP4901
BPH
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 320
Sex: MALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from baseline in total IPSS (International Prostate Symptom Score)
timeFrame: baseline and at the final evaluation (up to 5 weeks)
Secondary outcomes:
measure: Change from baseline in each symptom score of IPSS
timeFrame: baseline and at the final evaluation (up to 5 weeks)
measure: Change from baseline in IPSS QOL (quality of life) score
timeFrame: baseline and at the final evaluation (up to 5 weeks)
measure: Proportion of IPSS responder
timeFrame: baseline and at the final evaluation (up to 5 weeks)
measure: Plasma concentration of ASP4901
timeFrame: up to 5 weeks
measure: Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
timeFrame: up to 5 weeks
Other outcomes:
Locations:
city: Kansai
country: Japan
city: Kanto
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: