A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH (SATURN)

Astellas

Status and phase: Completed; Phase 2

Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Treatments: Drug: solifenacin succinate; Drug: tamsulosin hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510406

EudraCT number: 2006-002072-18

905-CL-052

Details and patient eligibility

About

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Full description

Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Enrollment: 919 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male patients with LUTS associated with BPH diagnosed > 3 months
• IPSS score > 13
• voiding and storage symptoms
• maximum flow rate of > 4 mL/s and < 15 mL/s

Exclusion criteria

• post void residual volume > 200 mL
• symptomatic urinary tract infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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919 participants in 8 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

B

Active Comparator group

Treatment:

Drug: solifenacin succinate

C

Active Comparator group

Treatment:

Drug: solifenacin succinate

D

Active Comparator group

Treatment:

Drug: solifenacin succinate

E

Active Comparator group

Treatment:

Drug: tamsulosin hydrochloride

F

Active Comparator group

Treatment:

Drug: solifenacin succinate

Drug: tamsulosin hydrochloride

G

Active Comparator group

Treatment:

Drug: solifenacin succinate

Drug: tamsulosin hydrochloride

H

Active Comparator group

Treatment:

Drug: solifenacin succinate

Drug: tamsulosin hydrochloride