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OpenTrials
Completed

NCT Number: NCT00694044

Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects

1. Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects. 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.

Completed

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Key information

Conditions

Healthy Non-Smoking

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy, Elderly (65-85 years inclusive), Non-smoker

Exclusion criteria

Creatinine Clearnace < 30 ml/min, Evidence or history of clinically significant, unstable diseases

Treatment and study plan

Varenicline

Drug

0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days

Other names: Champix, Chantix

Placebo

Drug

Placebo for 21 days

Primary outcomes

  1. Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)

    Time frame: 21 days

  2. Steady state pharmacokinetics

    Time frame: 21 days

  3. Effects on cognition (computerized battery of cognitive tests)

    Time frame: 21 days

Secondary outcomes

  1. No secondary outcomes.

    Time frame: Time frame n/a

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 10, 2008
Registry last updated
Jun 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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