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

Astellas

Status and phase: Completed; Phase 2

Conditions: Benign Prostate Hyperplasia

Treatments: Drug: Tamsulosin; Drug: Placebo; Drug: ASP4901

Study type: Interventional

Funder types: Industry

Identifiers

NCT02038868

4901-CL-0201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 320 patients

Sex: Male

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 3 patient groups, including a placebo group

ASP4901 group

Experimental group

Description:

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

Treatment:

Drug: ASP4901

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Tamsulosin group

Active Comparator group

Description:

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

Treatment:

Drug: Tamsulosin