A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

NCT ID: NCT00368706

Last Updated: 2008-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Keywords

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solifenacin Overactive bladder Urinary incontinence Treatment outcomes VESIcare

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

solifenacin succinate

Intervention Type DRUG

Oral

2

Group Type ACTIVE_COMPARATOR

tolterodine

Intervention Type DRUG

oral

Interventions

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solifenacin succinate

Oral

Intervention Type DRUG

tolterodine

oral

Intervention Type DRUG

Other Intervention Names

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Vesicare YM905

Eligibility Criteria

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Inclusion Criteria

* Patients willing and able to complete the micturition diary correctly
* Patients experiencing frequency of micturition as verified in the diary
* Patients experiencing significant post void residual volume
* OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion Criteria

* Significant post void residual volume
* Patients with indwelling catheters or practicing intermittent self- catheterization
* Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Inc.

Principal Investigators

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Use Central Contact

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Beijing, , China

Site Status

Chongqing, , China

Site Status

Hangzhou, , China

Site Status

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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90506/CHoTD01

Identifier Type: -

Identifier Source: org_study_id