Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms (Neptune II)

Astellas

Status and phase: Completed; Phase 3

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg); Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01021332

905-CL-057

2008-001212-20 (EudraCT Number)

Details and patient eligibility

About

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Full description

This is an open-label extension study following the double blind 905-CL-055 study

Enrollment: 1,067 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of 12 weeks double-blind treatment in Study 905-CL-055

Exclusion criteria

• Any significant PVR volume (>150 mL)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,067 participants in 1 patient group

Total Group

Experimental group

Description:

Participants who received at least one dose of open-label fixed dose combination (FDC) treatment

Treatment:

Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)

Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)