Effects Of Detrol LA On Memory And Cognition In Elderly Population
NCT00411437
ABOUT THIS STUDY
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- Male or female subjects with age of 65 - 75 years
- Having a score of greater than or equal to 26 on the Mini-Mental State Exam (MMSE)
- Current or history of bladder outlet obstruction. Previous history of acute urinary
retention requiring catheterization, or severe voiding difficulties in the judgment of
the investigator, prior to randomization
- Significant hepatic or renal disease, defined as twice the upper limit of the
reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or
creatinine
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Descriptive Information | ||||
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Brief Title ICMJE | Effects Of Detrol LA On Memory And Cognition In Elderly Population | |||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Three Arm Study To Evaluate The Effects Of Tolterodine ER 4 mg Vs. Placebo Vs. Oxybutynin ER On Memory And Other Cognitive Abilities In Elderly Subjects | |||
Brief Summary | The primary purpose of the trial is to show that tolterodine ER has no effect on memory and other cognitive abilities in an elderly population | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 220 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2007 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years to 75 Years (Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00411437 | |||
Other Study ID Numbers ICMJE | A6121154 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |