A Double-Blind, Paralleled Study Comparing Efficacy/Safet... | NCT00368706

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

NCT00368706

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Apr 10, 2008Estimated

Enrollment

246Actual

Phase

Phase 3

Conditions

Urinary Bladder, Overactive

Interventions

solifenacin succinate
tolterodine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Aug 24, 2006

First Submission Date that Met QC Criteria

Aug 24, 2006

First Posted Date

Aug 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2008

Last Update Posted Date

Apr 10, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

246Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: solifenacin succinate
2	Active Comparator		Drug: tolterodine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
solifenacin succinate	Drug	Oral	1	Vesicare YM905

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in mean number of micturitions per 24 hours		8 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in mean volume voided per micturition		8 Weeks
Change from baseline in mean number of incontinence episodes per 24 hours		8 Weeks
Change from baseline in mean urgency frequency per 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Use Central Contact	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing		100000	China

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069464	Solifenacin Succinate
D000068737	Tolterodine Tartrate

Ancestor Terms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided