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

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NCT01161472

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01161472
Pfizer
Completed
A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

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A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
A 4 Way Placebo And Active Controlled Study To Evaluate The Effects Of Fesoterodine On Cognitive Function In Healthy Elderly Subjects
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Evaluation of cognitive function
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01161472
A0221086
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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