Effects Of Detrol LA On Memory And Cognition In Elderly Population

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NCT00411437

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Study Location
Pfizer Investigational Site
Tucson, Arizona, 85741, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Memory, Cognition
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Memory, CognitionEffects Of Detrol LA On Memory And Cognition In Elderly Population
NCT00411437
  1. Tucson, Arizona
  2. Brooksville, Florida
  3. DeLand, Florida
  4. Naples, Florida
  5. Ocala, Florida
  6. Ocala, Florida
  7. St. Petersburg, Florida
  8. Tampa, Florida
  9. West Palm Beach, Florida
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Memory
  • Cognition
Intervention  ICMJE
  • Drug: Tolterodine ER
  • Drug: Oxybutynin ER
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
 (submitted: December 13, 2006)		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:

  • 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)

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

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