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Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

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: NCT00795509
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : July 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Urinary Bladder, Overactive
Intervention Drug: Tolterodine tartrate
Enrollment 374
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tolterodine Tartrate.
Hide Arm/Group Description Participants taking Tolterodine tartrate.
Period Title: Overall Study
Started 374
Completed 343
Not Completed 31
Reason Not Completed
Protocol Violation             31
Arm/Group Title Tolterodine Tartrate.
Hide Arm/Group Description Participants taking Tolterodine tartrate.
Overall Number of Baseline Participants 343
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
<65 years 98
>= 65 years 245
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants
Female
159
  46.4%
Male
184
  53.6%
Target disease severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
Mild 135
Moderate 194
Severe 14
[1]
Measure Description: The severity of Overactive Bladder which was diagnosed by investigator.
Complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
Present 266
Absent 77
Concomitant drug  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
Present 256
Absent 87
Treatment Period  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants
Less than 12 weeks 1
12 to 24 weeks 44
24 to 52 weeks 88
52 to 76 weeks 172
76 to 104 weeks 31
Over 104 weeks 7
1.Primary Outcome
Title Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).
Hide Description All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.
Arm/Group Title Tolterodine Tartrate.
Hide Arm/Group Description:
Participants taking Tolterodine tartrate.
Overall Number of Participants Analyzed 343
Measure Type: Number
Unit of Measure: participants
Glaucoma 1
Death 1
Abdominal discomfort 1
2.Primary Outcome
Title Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
Hide Description All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.
Arm/Group Title Tolterodine Tartrate.
Hide Arm/Group Description:
Participants taking Tolterodine tartrate.
Overall Number of Participants Analyzed 343
Measure Type: Number
Unit of Measure: participants
25
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Tolterodine Tartrate.
Hide Arm/Group Description Participants taking Tolterodine tartrate.
All-Cause Mortality
Tolterodine Tartrate.
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tolterodine Tartrate.
Affected / at Risk (%) # Events
Total   1/343 (0.29%)    
General disorders   
Death  1  1/343 (0.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/J13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tolterodine Tartrate.
Affected / at Risk (%) # Events
Total   25/343 (7.29%)    
Eye disorders   
Glaucoma  1  1/343 (0.29%)  1
Gastrointestinal disorders   
Constipation  1  6/343 (1.75%)  6
Abdominal discomfort  1  1/343 (0.29%)  1
General disorders   
Thirst  1  6/343 (1.75%)  6
Nervous system disorders   
Dizzines  1  1/343 (0.29%)  1
Renal and urinary disorders   
Dysuria  1  8/343 (2.33%)  8
Urinary retention  1  4/343 (1.17%)  4
Residual urine volume increased  1  3/343 (0.87%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/J13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00795509     History of Changes
Other Study ID Numbers: A6121187
First Submitted: November 19, 2008
First Posted: November 21, 2008
Results First Submitted: March 7, 2012
Results First Posted: July 9, 2012
Last Update Posted: July 9, 2012