Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)

Astellas

Status and phase: Completed; Phase 3

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg; Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg; 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); Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg; Drug: tamsulosin hydrochloride OCAS 0.4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018511

2008-001211-37 (Other Identifier)

905-CL-055

Details and patient eligibility

About

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

Enrollment: 1,334 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
• A total International Prostate Symptom Score (IPSS) of ≥13
• A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
• A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion criteria

• Any significant Post Void Residual volume (>150 mL)
• A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound
• Evidence of a symptomatic urinary tract infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,334 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Treatment:

Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg

Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg

Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg

TOCAS 0.4 mg

Active Comparator group

Description:

Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Treatment:

Drug: tamsulosin hydrochloride OCAS 0.4 mg

Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg

Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg

FDC 0.4 mg/6 mg

Experimental group

Description:

Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Treatment:

Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg

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

Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg

FDC 0.4 mg/9 mg

Experimental group

Description:

Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet

Treatment:

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

Drug: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg

Drug: Placebo tamsulosin hydrochloride OCAS 0.4 mg