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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00454896
First received: March 29, 2007
Last updated: September 17, 2014
Last verified: September 2014
  Purpose
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Condition Intervention Phase
Urinary Bladder, Overactive Drug: VESIcare® Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

Enrollment: 739
Study Start Date: May 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: VESIcare®
Oral
Other Names:
  • solifenacin succinate
  • YM905
Placebo Comparator: 2 Drug: placebo
Oral

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454896

  Show 65 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00454896     History of Changes
Other Study ID Numbers: 905-UC-005
Study First Received: March 29, 2007
Last Updated: September 17, 2014

Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive
Urgency
VESIcare®
Solifenacin succinate

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on September 21, 2017