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A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB) (VENUS)

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: NCT00454896
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: VESIcare® Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 739 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder
Study Start Date : May 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: VESIcare®
Other Names:
  • solifenacin succinate
  • YM905

Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  1. Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome [ Time Frame: Weeks 1, 4, 8 and 12 ]

Secondary Outcome Measures :
  1. Improvement of urgency [ Time Frame: Weeks 1, 4, 8 and 12 ]
  2. Improvement of frequency, incontinence and nocturia [ Time Frame: Weeks 1, 4, 8 and 12 ]
  3. Number of patients satisfied with treatment [ Time Frame: Weeks 1, 4, 8 and 12 ]
  4. Assessment of the efficacy [ Time Frame: End of study ]
  5. Evaluation of the safety and tolerability [ Time Frame: Baseline to end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
  • Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
  • Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion Criteria:

  • Previous treatment with darifenacin
  • Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
  • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
  • Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
  • Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator

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): NCT00454896

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Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Use Central Contact Astellas Pharma US, Inc.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc Identifier: NCT00454896    
Other Study ID Numbers: 905-UC-005
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive
Solifenacin succinate
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents