A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

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NCT01161472

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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult healthy volunteers 65 years and over with minimum MMSE of 26

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


- Prohibited concomitant medications


- Confounding medical conditions


- Clinically significant comorbid diseases


- Hypersensitivity or contraindications to fesoterodine or active control

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
Official Title  ICMJE A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
Brief Summary The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Detailed Description Evaluation of cognitive function
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 4mg fesoterodine
    4mg tablet once daily for 6 days
  • Drug: 8mg fesoterodine
    4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days
  • Drug: alprazolam 1mg
    1mg tablet once on last day of treatment period at clinic
  • Drug: Placebo
    Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
Study Arms  ICMJE
  • Experimental: 4mg fesoterodine
    Intervention: Drug: 4mg fesoterodine
  • Experimental: fesoterodine 8mg
    Intervention: Drug: 8mg fesoterodine
  • Active Comparator: 1mg alprazolam
    Intervention: Drug: alprazolam 1mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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
Actual Enrollment  ICMJE
 (submitted: July 12, 2010)		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult healthy volunteers 65 years and over with minimum MMSE of 26

Exclusion Criteria:

  • Prohibited concomitant medications
  • Confounding medical conditions
  • Clinically significant comorbid diseases
  • Hypersensitivity or contraindications to fesoterodine or active control
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 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 NCT01161472
Other Study ID Numbers  ICMJE A0221086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012

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