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

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. Identifier: NCT00368706
Recruitment Status : Completed
First Posted : August 25, 2006
Last Update Posted : April 10, 2008
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: solifenacin succinate Drug: tolterodine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
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
Study Start Date : September 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: solifenacin succinate
Other Names:
  • Vesicare
  • YM905
Active Comparator: 2 Drug: tolterodine

Primary Outcome Measures :
  1. Change from baseline in mean number of micturitions per 24 hours [ Time Frame: 8 Weeks ]

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

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

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

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 identifier (NCT number): NCT00368706

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

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

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

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