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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00463541
First received: April 19, 2007
Last updated: July 9, 2008
Last verified: July 2008
History of Changes

April 19, 2007
July 9, 2008
June 2004
April 2005   (final data collection date for primary outcome measure)
To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).
Complete list of historical versions of study NCT00463541 on ClinicalTrials.gov Archive Site
  • Percentage of patients satisfied with 5mg treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining additional benefit with increase to 10mg dose [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Assess: most bothersome OAB symptom at baseline; % satisfied with 5mg treatment; % obtain additional benefit with increase to 10mg dose
  • satisfaction with treatment for patients completing 12 weeks of treatment; safety and tolerability of 5 and 10mg Vesicare
Not Provided
Not Provided
 
Open-Label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
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

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).

Study included a 24 week extension that did not occur due to FDA approval of the product.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Bladder, Overactive
Drug: solifenacin succinate
oral
Other Names:
  • VESIcare (R)
  • YM905
Experimental: 1
Intervention: Drug: solifenacin succinate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2225
April 2005
April 2005   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00463541
905-UC-007
No
Sr. Manager, Clinical Trials Registry, Astellas Pharma US, Inc.
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma US, Inc.
Astellas Pharma Inc
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP