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NCT00691483 · ClinicalTrials.gov registry record · Phase 4
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
A Phase 4 study of Smoking Cessation, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 659
- Enrollment target
- 20
- Study locations
NCT00691483: Completed Phase 4 study of Smoking Cessation, sponsored by Pfizer.
NCT00691483 is a Phase 4 study of Smoking Cessation that has completed, run by Pfizer. The registered enrollment target is 659 participants, above the 471-participant average among 188 other Smoking Cessation trials with a reported enrollment target (40% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00691483, a Phase 4 study of Smoking Cessation, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 659 participants
- Enrollment target
- 20
- Study locations
Study Summary
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
Primary Outcome
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \>10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm.
Conditions Studied
Interventions
- DRUG placebo
- DRUG varenicline
Study Locations (20)
Other
- Pfizer Investigational Site - Buenos Aires
- Pfizer Investigational Site - Beijing
- Pfizer Investigational Site - Guangzhou
- Pfizer Investigational Site - Brno
California
- Pfizer Investigational Site - Los Angeles
- Pfizer Investigational Site - Santa Ana
Pennsylvania
- Pfizer Investigational Site - Bridgeville
- Pfizer Investigational Site - Philadelphia
Arizona
- Pfizer Investigational Site - Litchfield Park
Kansas
- Pfizer Investigational Site - Overland Park
Kentucky
- Pfizer Investigational Site - Lexington
Massachusetts
- Pfizer Investigational Site - Milford
Nebraska
- Pfizer Investigational Site - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 659 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00691483 record still lists
NCT00691483 is an interventional study that assigns participants to a tested intervention. The registered 659 participants enrollment target is mid-sized for trials with a published cap, above the 471-participant average among 188 other Smoking Cessation trials with a reported enrollment target (40% higher).
The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00691483 names 20 study sites across 15 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00691483 about?
NCT00691483 is a clinical study titled "Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date". The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
What is the current status of trial NCT00691483?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 659 participants. The study started on 2008-09. Estimated completion is 2009-12.
What conditions does trial NCT00691483 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT00691483?
The interventions under investigation include: placebo (DRUG), varenicline (DRUG).
Who is sponsoring clinical trial NCT00691483?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00691483 being conducted?
This trial has 20 study locations across Arizona, California, Kansas, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00691483's enrollment target sits among peer trials
659 40th of 188 higher than 149 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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