Back to resultsA Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
Primary Purpose
Benign Prostate Hyperplasia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ASP4901
Tamsulosin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostate Hyperplasia focused on measuring ASP4901, BPH
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
ASP4901 group
Placebo group
Tamsulosin group
Arm Description
After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).
After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).
After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).
Outcomes
Primary Outcome Measures
Change from baseline in total IPSS (International Prostate Symptom Score)
Secondary Outcome Measures
Change from baseline in each symptom score of IPSS
Change from baseline in IPSS QOL (quality of life) score
Proportion of IPSS responder
"IPSS responder" is defined as 25% improvement in IPSS
Plasma concentration of ASP4901
only for ASP4901 group
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02038868
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2013 (Actual)
Primary Completion Date
April 4, 2014 (Actual)
Study Completion Date
April 4, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia
Keywords
ASP4901, BPH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP4901 group
Arm Type
Experimental
Arm Description
After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).
Arm Title
Tamsulosin group
Arm Type
Active Comparator
Arm Description
After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).
Intervention Type
Drug
Intervention Name(s)
ASP4901
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
YM617, Harnal
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline in total IPSS (International Prostate Symptom Score)
Time Frame
baseline and at the final evaluation (up to 5 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline in each symptom score of IPSS
Time Frame
baseline and at the final evaluation (up to 5 weeks)
Title
Change from baseline in IPSS QOL (quality of life) score
Time Frame
baseline and at the final evaluation (up to 5 weeks)
Title
Proportion of IPSS responder
Description
"IPSS responder" is defined as 25% improvement in IPSS
Time Frame
baseline and at the final evaluation (up to 5 weeks)
Title
Plasma concentration of ASP4901
Description
only for ASP4901 group
Time Frame
up to 5 weeks
Title
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Time Frame
up to 5 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Kansai
Country
Japan
City
Kanto
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=291
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
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