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Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

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ClinicalTrials.gov Identifier: NCT00444925
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : September 3, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: fesoterodine fumarate Drug: placebo Drug: tolterodine tartrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)
Study Start Date : April 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fesoterodine
Tablets
Drug: fesoterodine fumarate
4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks

Placebo Comparator: Placebo
Tablets and capsules
Drug: placebo
once daily (OD)for 12 weeks

Active Comparator: Tolterodine
Capsules
Drug: tolterodine tartrate
4 mg once daily (OD) for 12 weeks




Primary Outcome Measures :
  1. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment). [ Time Frame: Baseline, Week 12 ]
    UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4. [ Time Frame: Baseline, Week 1, Week 4 ]
    UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

  2. Percent Change From Baseline of UUI Episodes Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.

  3. Change From Baseline in Mean Voided Volume Per Micturition. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.

  4. Change From Baseline in Mean Number of Micturitions Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.

  5. Percent Change From Baseline of Micturitions Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).

  6. Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.

  7. Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.

  8. Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

  9. Percent Change From Baseline of Urgency Episodes Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  10. Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

  11. Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  12. Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

  13. Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.

  14. Change From Baseline in Patient Perception of Bladder Condition (PPBC). [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ]
    Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.

  15. Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]
    Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.

  16. Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment). [ Time Frame: Baseline, Week 12 ]
    Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.

  17. Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). [ Time Frame: Baseline, Week 12 ]
    HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.



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

Inclusion Criteria:

  • Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

  • Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
  • Patients with significant hepatic and renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

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): NCT00444925


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Locations
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United States, Alabama
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Homewood, Alabama, United States, 35209
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Huntsville, Alabama, United States, 35801
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Mobile, Alabama, United States, 36608
United States, California
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Carmichael, California, United States, 95608
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Orangevale, California, United States, 95662
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San Diego, California, United States, 92103-6204
United States, Colorado
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Aurora, Colorado, United States, 80012
United States, Connecticut
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Waterbury, Connecticut, United States, 06708
United States, Florida
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Miami, Florida, United States, 33186
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Wellington, Florida, United States, 33414
United States, Georgia
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Atlanta, Georgia, United States, 30342
United States, Idaho
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Coeur D Alene, Idaho, United States, 83814
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Sandpoint, Idaho, United States, 83864
United States, Illinois
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Aurora, Illinois, United States, 60504
United States, Iowa
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West Des Moines, Iowa, United States, 50266
United States, Kansas
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Newton, Kansas, United States, 67114
United States, Louisiana
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Shrevport, Louisiana, United States, 71106
United States, Massachusetts
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Watertown, Massachusetts, United States, 02472
United States, Minnesota
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Chaska, Minnesota, United States, 55318
United States, New Jersey
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Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
United States, New York
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Garden City, New York, United States, 11530
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Mineola, New York, United States, 11501
United States, North Carolina
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Burlington, North Carolina, United States, 27215
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Concord, North Carolina, United States, 28025
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Huntersville, North Carolina, United States, 28078
United States, Ohio
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Dayton, Ohio, United States, 45439
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Allentown, Pennsylvania, United States, 18103
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Allentown, Pennsylvania, United States, 18106
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Pittsburgh, Pennsylvania, United States, 15212
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Pittsburgh, Pennsylvania, United States, 15213-3180
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East Providence, Rhode Island, United States, 02914
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29201
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Kingsport, Tennessee, United States, 37660
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Provo, Utah, United States, 84604
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Chesapeake, Virginia, United States, 23320
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Seattle, Washington, United States, 98104
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Menomonee Falls, Wisconsin, United States, 53051
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Antwerpen, Belgium, 2020
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Bruxelles, Belgium, 1070
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Kortrijk, Belgium, 8500
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Tessenderlo, Belgium, 3980
Brazil
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Salvador, BA, Brazil, 40420-000
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Rio de Janeiro, RJ, Brazil, CEP 20551-030
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Porto Alegre, RS, Brazil, 90020-090
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Porto Alegre, RS, Brazil, 90470-340
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Campinas, SP, Brazil, 13084-882
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São Paulo, SP, Brazil, 04039-901
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São Paulo, SP, Brazil, 04262-000
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Calgary, Alberta, Canada, T2V 4R6
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Edmonton, Alberta, Canada, T5H 3V9
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Victoria, British Columbia, Canada, V8V 3N1
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Rancagua, VI Región, Chile, 2820945
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Czech Republic
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Hradec Kralove, Czech Republic, 500 02
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Jablonec nad Nisou, Czech Republic, 466 60
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Jindrichuv Hradec, Czech Republic, 377 38
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Denmark
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Aalborg, Denmark, 9100
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Aarhus N, Denmark, 8200
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Herlev, Denmark, 2730
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Roskilde, Denmark, 4000
Germany
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Ahaus, Germany, 41683
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Alzey, Germany, 55232
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Berlin, Germany, 10787
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Berlin, Germany, 13125
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Berlin, Germany, 13347
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Karlsruhe, Germany, 76199
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Krumbach, Germany, 86381
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Leipzig, Germany, 04105
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Leipzig, Germany, 04109
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Marburg, Germany, 35039
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Muelheim a.d. Ruhr, Germany, 45468
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Muenchen, Germany, 81241
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Rosenheim, Germany, 83022
Greece
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Athens, Attiki, Greece, 10552
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Ioannina, Ipiros, Greece, 45001
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Rio, Patras, Greece, 26500
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Hungary
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Debrecen, Hungary, 4026
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Szeged, Hungary, 6725
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India
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Hyderabad, Andhra Pradesh, India, 500 001
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Hyderabad, Andhra Pradesh, India, 500 082
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Bangalore, Karnataka, India, 560 034
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Lucknow, Uttar Pradesh, India, 226003
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Latina, Italy, 04100
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Padova, Italy, 35128
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Siena, Italy, 53100
Korea, Republic of
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Seoul, Korea, Korea, Republic of, 110-744
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Daegu, Korea, Republic of, 705-718
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Seoul, Korea, Republic of, 100-380
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 137-040
Malaysia
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Batu Caves, Selangor, Malaysia, 68100
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Kuala Lumpur, Malaysia, 59100
Norway
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Bergen, Norway, 5005
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Hamar, Norway, 2317
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Lysaker, Norway, 1366
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Oslo, Norway, 0264
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Oslo, Norway, NO-0257
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Sandnes, Norway, 4313
Peru
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Surco, Lima, Peru, L33
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Lima, Peru, L27
Poland
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Bialystok, Poland, 15-950
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Bydgoszcz, Poland, 85-168
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Lodz, Poland, 91-463
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Szczecin, Poland, 70-11
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Warszawa, Poland, 02-507
Romania
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Arad, Romania, 310175
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Bucuresti, Romania, 041345
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Bucuresti, Romania, 050653
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Sibiu, Romania, 550245
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Timisoara, Romania, 300736
Russian Federation
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Moscow, Russia, Russian Federation, 105425
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St. Petersburg, Russia, Russian Federation
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Moscow, Russian Federation, 101000
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Moscow, Russian Federation, 115516
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Moscow, Russian Federation, 117815
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Rostov-on-Don, Russian Federation, 344022
Singapore
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Singapore, Singapore, 119074
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Singapore, Singapore, 229899
South Africa
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Bloemfontein, Free State, South Africa, 9300
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Parktown, Gauteng Province, South Africa, 2193
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Vosloorus, Gauteng, South Africa, 1475
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Durban, Kwa Zulu Natal, South Africa, 4001
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Pietermaritzburg, Kwa Zulu Natal, South Africa, 3201
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Cape Town, South Africa, 8001
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Pretoria, South Africa, 0083
Spain
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Getafe, Madrid, Spain, 28905
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Bilbao, Vizcaya, Spain, 48013
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Madrid, Spain, 28046
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Valencia, Spain, 46010
Sweden
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Huskvarna, Sweden, 561 36
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Lulea, Sweden, 97180
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Malmo, Sweden, 205 02
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Skovde, Sweden, 541 30
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Stockholm, Sweden
Switzerland
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Frauenfeld, Switzerland, CH-8500
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Luzern 16, Switzerland, CH-6000
Taiwan
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Niao-Sung Hsiang, Kaohsiung, Taiwan, 833
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Hualien, Taiwan, 970
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Taichung City, Taiwan, 40705
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Taipei, Taiwan, 100
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Taipei, Taiwan
Ukraine
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Chernivtsi, Ukraine, 58002
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Kharkiv, Ukraine, 61037
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Kyiv, Ukraine, 04053
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Odessa, Ukraine, 65000
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Zaporizhzhia, Ukraine, 69000
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00444925     History of Changes
Other Study ID Numbers: A0221008
First Posted: March 8, 2007    Key Record Dates
Results First Posted: September 3, 2009
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Urinary Bladder Diseases
Urologic Diseases
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents