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NCT01244061 · ClinicalTrials.gov registry record · Phase 4
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
A Phase 4 study of Smoking Cessation, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 498
- Enrollment target
- 20
- Study locations
NCT01244061: Completed Phase 4 study of Smoking Cessation, sponsored by Pfizer.
NCT01244061 is a Phase 4 study of Smoking Cessation that has completed, run by Pfizer. The registered enrollment target is 498 participants, roughly in line with the 472-participant average among 188 other Smoking Cessation trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01244061, a Phase 4 study of Smoking Cessation, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 498 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
Primary Outcome
The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)\> 10ppm at any visits during this time frame.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Varenicline
Study Locations (20)
Other
- Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie - Edegem
- Universitaire Ziekenhuizen Leuven/Pneumologie - Leuven
- Centre Hospitalier Universitaire de Liege - Liège
- Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire - Yvoir
California
- Ronald Reagan University of California Los Angeles Medical Center - Los Angeles
- University of California Los Angeles David Geffen School of Medicine - Los Angeles
Queensland
- Royal Brisbane and Women's Hospital - Herston
- AusTrials Australia - Sherwood
Florida
- Avail Clinical Research, LLC - DeLand
Kentucky
- Central Kentucky Research Associates, Inc. - Lexington
Maryland
- The University of Maryland - College Park
Missouri
- The Center for Pharmaceutical Research, PC - Kansas City
Oregon
- Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT01244061 record still lists
NCT01244061 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 472-participant average among 188 other Smoking Cessation trials with a reported enrollment target.
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.
NCT01244061 names 20 study sites across 15 states, led by Other, California, Queensland.
Frequently Asked Questions
What is clinical trial NCT01244061 about?
NCT01244061 is a clinical study titled "A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider". The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks afte...
What is the current status of trial NCT01244061?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 498 participants. The study started on 2010-12. Estimated completion is 2012-11.
What conditions does trial NCT01244061 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT01244061?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG).
Who is sponsoring clinical trial NCT01244061?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01244061 being conducted?
This trial has 20 study locations across California, Florida, Kentucky, Maryland, Missouri. 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 NCT01244061's enrollment target sits among peer trials
498 58th of 188 higher than 131 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.
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