A Study of YM178 in Patients With Symptomatic Overactive Bladder

Astellas

Status and phase: Completed; Phase 2

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Placebo; Drug: YM178

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527033

178-CL-045

Details and patient eligibility

About

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Full description

To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Enrollment: 842 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 20 years suffering from overactive bladder

Exclusion criteria

• Pregnant and breastfeeding women
• Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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842 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Oral

Treatment:

Drug: YM178

2

Experimental group

Description:

Oral

Treatment:

Drug: YM178

3

Experimental group

Description:

Oral

Treatment:

Drug: YM178

4

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo