A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Overactive Bladder
Both
Overactive Bladder
Trial Information
A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.
Inclusion Criteria:
- 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence
episodes per 24 hours and minimum of 8 micturitions per 24 hours.
Exclusion Criteria:
- Other concurrent and concomitant medication or disease that could put the subjects at
additional risk or interfere with the study results.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Change in mean number of urgency urinary incontinence episodes per 24 hours at week 12 relative to baseline
Outcome Time Frame:
Baseline, Week 12
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A0221095
NCT ID:
NCT01302067
Start Date:
May 2011
Completion Date:
January 2013
Related Keywords:
- Overactive Bladder
- Urinary Bladder, Overactive
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|---|---|
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| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| PAB Clinical Research | Brandon, Florida 33511 |
| Advanced Clinical Concepts | Temple, Pennsylvania 19560 |
| Heartland Research Associates, LLC | Wichita, Kansas 67207 |
| Urological Surgeons of Long Island | Garden City, New York 11530 |
| Medisphere Medical Research Center, LLC | Evansville, Indiana 47714 |
| Triangle Urological Group | Pittsburgh, Pennsylvania 15212 |
| Pulmonary Associates of Brandon | Brandon, Florida |
| Medical and Surgical Specialists | Galesburg, Illinois 61401 |
| Metropolitan Urology | Jeffersonville, Indiana 47130 |
| Jacksonville Center for Clinical Research | Jacksonville, Florida 32216 |
| Medical Affiliated Research Center, Inc. | Huntsville, Alabama 35801 |
| American Health Research | Charlotte, North Carolina 28207 |
| Omega Medical Research | Warwick, Rhode Island 02886 |
| Mercy Health Research | St. Louis, Missouri 63141 |
| Mississippi Urology Clinic | Jackson, Mississippi 39202 |
| United Medical Associates | Johnson City, New York 13790 |
| Clinical Research Center of Nevada | Las Vegas, Nevada 89104 |
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| Fleming Island Center for Clinical Research | Fleming Island, Florida 32003 |
| M & O Clinical Research, LLC | Fort Lauderdale, Florida 33316 |
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| OB-GYN Associates of Mid-Florida, PA | Leesburg, Florida 34748 |
| New Horizon Research Center | Miami, Florida 33175 |
| Broward Research Group | Pembroke Pines, Florida 33026 |
| Clinical Research of Central Florida | Plant City, Florida 33563 |
| Advanced OBGYN Associates | West Palm Beach, Florida 33409 |
| North Fulton Urology, PC | Roswell, Georgia 30076 |
| North Georgia Clinical Research | Woodstock, Georgia 30189 |
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| Women's Health Practice | Champaign, Illinois 61820 |
| Center for Women's Research | Chicago, Illinois 60612 |
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| American Health Network of Indiana, LLC | Avon, Indiana 46123 |
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| Health Science Research Center | Pratt, Kansas 67124 |
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| Clinical Research Institute of Michigan, LLC | Chesterfield, Michigan 48047 |
| Midwest Pharmaceutical Research | St. Peters, Missouri 63376 |
| Lincoln Internal Medicine Associates | Lincoln, Nebraska 68516 |
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| Virtua Phoenix Ob-Gyn | Moorestown, New Jersey 08057 |
| Premier Research, Inc. | Trenton, New Jersey 08611 |
| Mid Hudson Medical Research, PLLC | New Windsor, New York 12553 |
| Upstate Clinical Research Associates | Williamsville, New York 14221 |
| Carolina Urology Partners, PLLC | Concord, North Carolina 28025 |
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| University Medical Associates | Huntersville, North Carolina 28078 |
| Wake Research Associates, LLC | Raleigh, North Carolina 27612 |
| Wake Internal Medicine Consultants, Inc. | Raleigh, North Carolina 27612 |
| PMG Research of Wilmington, LLC | Wilmington, North Carolina 28401 |
| Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates | Winston-Salem, North Carolina 27103 |
| Patient Priority Clinical Sites, LLC | Cincinnati, Ohio 45215 |
| Rapid Medical Research, Inc. | Cleveland, Ohio 44122 |
| Columbus Clinical Research | Columbus, Ohio 43213 |
| Columbus Center for Women's Health Research | Columbus, Ohio 43213 |
| Hometown Urgent Care and Research | Dayton, Ohio 45432 |
| Ohio Clinical Research, LLC | Willoughby Hills, Ohio 44094 |
| The Office of Johnny B. Roy, MD | Edmond, Oklahoma 73034 |
| Legacy Clinical Research, LLC | Oklahoma City, Oklahoma 73109 |
| Institute for Female Pelvic Medicine | Allentown, Pennsylvania 18103 |
| Laurel Highlands OB/GYN | Hopwood, Pennsylvania 15445 |
| The Clinical Trial Center, LLC | Jenkintown, Pennsylvania 19046 |
| Richard Kastelic and Associates | Johnstown, Pennsylvania 15405 |
| Clinical Trials Research Services, LLC | Pittsburgh, Pennsylvania 15206 |
| Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group | State College, Pennsylvania 16801 |
| Pish Medical Associates | Uniontown, Pennsylvania 15401 |
| Woman's Clinic Ltd. | West Reading, Pennsylvania 19611 |
| Coastal Medical | East Greenwich, Rhode Island 02818 |
| Safe Harbor Clinical Research | East Providence, Rhode Island 02914 |
| TLM Medical Services, LLC | Columbia, South Carolina 29204 |
| Coastal Carolina Research Center | Mt. Pleasant, South Carolina 29464 |
| Southern Urogynecology | West Columbia, South Carolina 29169 |
| PMG Research of Bristol, LLC | Bristol, Tennessee 37620 |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol, Tennessee 37620 |
| Adams Patterson Gynocology and Obstetrics, PLLC | Memphis, Tennessee 38120 |
| Heartland Medical PC | New Tazewell, Tennessee 37825 |
| Austin Center for Clinical Research | Austin, Texas 78756 |
| RJE Clinical Research | Dallas, Texas 75224 |
| Memorial Clinical Associates dba MCA Research | Houston, Texas 77079 |
| Urologic Consultants of Houston, P.A. | Houston, Texas 77074 |
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| Clinical Trials of Texas, Inc. | San Antonio, Texas 78229 |
| Scott and White Healthcare | Temple, Texas 76502 |
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| Dean Oregon Clinic | Oregon, Wisconsin 53575 |
| Allegiance Research Specialists | Wauwatosa, Wisconsin 53226 |
