Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers
NCT ID: NCT00527150
Last Updated: 2010-01-11
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
48 participants
INTERVENTIONAL
2007-10-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Varenicline Tartrate
Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.
Cohort 2
Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Varenicline Tartrate
Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
Cohort 3
Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Varenicline Tartrate
Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
Optional Cohort 4
Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Varenicline Tartrate
The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
Optional Cohort 5
Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Varenicline Tartrate
The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
Interventions
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Varenicline Tartrate
Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.
Varenicline Tartrate
Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
Varenicline Tartrate
Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
Varenicline Tartrate
The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
Varenicline Tartrate
The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
Eligibility Criteria
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Inclusion Criteria
* Currently smoking and have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 continuous months in the past year.
Exclusion Criteria
* Pregnant or nursing women are excluded; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to study medication administration until completion of protocol-required procedures are excluded.
* Subjects with an estimated creatinine clearance (CLcr) \<80 mL/min derived using the method of Cockcroft and Gault.
18 Years
55 Years
ALL
No
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
East Grand Forks, Minnesota, United States
Pfizer Investigational Site
Fargo, North Dakota, 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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A3051069
Identifier Type: -
Identifier Source: org_study_id
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