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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly titration | Active Comparator |
| |
| Two Week QD | Active Comparator |
| |
| Two Week BID | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales) | 21 days | |
| Steady state pharmacokinetics | 21 days | |
| Effects on cognition (computerized battery of cognitive tests) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcomes. | Time frame n/a |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Miami | Florida | 33169 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| varenicline | Drug | 0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days |
|
|
| varenicline | Drug | 0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days |
|
|
| Placebo | Drug | Placebo for 21 days |
|
| Orlando |
| Florida |
| 32809 |
| United States |
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
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