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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:
ClinicalTrials.gov Identifier:
NCT00368706
First Posted: August 25, 2006
Last Update Posted: April 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Change from baseline in mean volume voided per micturition [ Time Frame: 8 Weeks ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: 8 Weeks ]
  • Change from baseline in mean urgency frequency per 24 hours [ Time Frame: 8 Weeks ]
  • Change from baseline in mean nocturia episodes per 24 hours [ Time Frame: 8 Weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00368706     History of Changes
Other Study ID Numbers: 90506/CHoTD01
First Submitted: August 24, 2006
First Posted: August 25, 2006
Last Update Posted: April 10, 2008
Last Verified: April 2008

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents