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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00368706
First received: August 24, 2006
Last updated: April 9, 2008
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Urinary Bladder, Overactive
 Drug: solifenacin succinate
Drug: tolterodine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in mean number of micturitions per 24 hours [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean volume voided per micturition [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean urgency frequency per 24 hours [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean nocturia episodes per 24 hours [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: solifenacin succinate
Oral
Other Names:
  • Vesicare
  • YM905
Active Comparator: 2 Drug: tolterodine
oral

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368706

Locations
China
Beijing, China, 100000
Chong Qing, China, 404000
Hang Zhou, China, 310000
Shanghai, China, 200000
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Principal Investigator: Use Central Contact Peking University First Hospital
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00368706     History of Changes
Other Study ID Numbers: 90506/CHoTD01
Study First Received: August 24, 2006
Last Updated: April 9, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
solifenacin
Overactive bladder
Urinary incontinence
Treatment outcomes
VESIcare

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013