Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects
NCT ID: NCT00694044
Last Updated: 2009-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2008-04-30
2008-06-30
Brief Summary
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2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects.
3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Weekly titration
varenicline
0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days
Two Week QD
varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
Two Week BID
varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Placebo
Placebo
Placebo for 21 days
Interventions
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varenicline
0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days
varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Placebo
Placebo for 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
65 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051106
Identifier Type: -
Identifier Source: org_study_id
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