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Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms (VOLT)

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.
ClinicalTrials.gov Identifier: NCT00463541
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

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

Detailed Description:
Study included a 24 week extension that did not occur due to FDA approval of the product.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2225 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial
Study Start Date : June 2004
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: solifenacin succinate
oral
Other Names:
  • VESIcare (R)
  • YM905


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms [ Time Frame: Weeks 4, 8 and 12 ]

Secondary Outcome Measures :
  1. Percentage of patients satisfied with 5mg treatment [ Time Frame: Week 12 ]
  2. Percentage of patients obtaining additional benefit with increase to 10mg dose [ Time Frame: week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
  • Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. 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.

Exclusion Criteria:

  • -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
  • Clinically significant outflow obstruction (benign prostatic hyperplasia)
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): NCT00463541


  Show 198 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: NCT00463541     History of Changes
Other Study ID Numbers: 905-UC-007
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 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