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

NCT02038868 | Completed Phase 2

• 1 other identifier: 4901-CL-0201
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Benign Prostate Hyperplasia

Keywords

ASP4901; BPH

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total IPSS (International Prostate Symptom Score)

  baseline and at the final evaluation (up to 5 weeks)

Secondary Outcomes (5)

• 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)

• Plasma concentration of ASP4901

  up to 5 weeks

• Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs

  up to 5 weeks

Study Arms (3)

ASP4901 group

EXPERIMENTAL

After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).

Drug: ASP4901

Placebo group

PLACEBO COMPARATOR

After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).

Drug: Placebo

Tamsulosin group

ACTIVE COMPARATOR

After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).

Drug: Tamsulosin

Interventions

ASP4901 DRUG

oral

ASP4901 group

Tamsulosin DRUG

oral

Also known as: YM617, Harnal

Tamsulosin group

Placebo DRUG

oral

Placebo group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: July 22, 2013
• Primary Completion: April 4, 2014
• Study Completion: April 4, 2014
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)