A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia

Benign Prostate Hyperplasia Clinical Trial

Official title:

Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038868
• Other study ID #: 4901-CL-0201
• Status: Completed
• Phase: Phase 2
• Start date: July 22, 2013
• Est. completion date: April 4, 2014

Study information

• Verified date: June 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 4, 2014
• Est. primary completion date: April 4, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• ASP4901
oral
• Tamsulosin
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total IPSS (International Prostate Symptom Score)		baseline and at the final evaluation (up to 5 weeks)
Secondary	Change from baseline in each symptom score of IPSS		baseline and at the final evaluation (up to 5 weeks)
Secondary	Change from baseline in IPSS QOL (quality of life) score		baseline and at the final evaluation (up to 5 weeks)
Secondary	Proportion of IPSS responder	"IPSS responder" is defined as 25% improvement in IPSS	baseline and at the final evaluation (up to 5 weeks)
Secondary	Plasma concentration of ASP4901	only for ASP4901 group	up to 5 weeks
Secondary	Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs		up to 5 weeks

External Links

•   Link to results on the Astellas Clinical Study Results website