Smoking CessationPhase 3NCT00143325
An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
A Phase 3 study testing varenicline (CP-526,555) in people with Smoking Cessation, run by Pfizer at 22 sites in 5 countries.
Trial summary
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- varenicline (CP-526,555)
- How many people
- 730 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Jan 2005to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have smoked an average of at least 15 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Who cannot join
- Subjects with clinically significant cardiovascular disease in the past 6 months.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
United States6 sites
Pfizer Investigational Site
Farmington, Connecticut
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Palo Alto, California
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Santa Ana, California
Pfizer Investigational Site
Worcester, Massachusetts
France6 sites
Pfizer Investigational Site
Caen
Pfizer Investigational Site
Clermont-Ferrand
Pfizer Investigational Site
Limeil-Brévannes
Pfizer Investigational Site
Metz
Pfizer Investigational Site
Paris
Pfizer Investigational Site
Vandœuvre-lès-Nancy
Netherlands4 sites
Pfizer Investigational Site
Amsterdam
Pfizer Investigational Site
Enschede
Pfizer Investigational Site
Maastricht
Pfizer Investigational Site
Zutphen
Belgium3 sites
Pfizer Investigational Site
Brussels
Pfizer Investigational Site
Edegem
Pfizer Investigational Site
Ghent
United Kingdom3 sites
Pfizer Investigational Site
London, Surrey
Pfizer Investigational Site
London
Pfizer Investigational Site
Nottingham
About this study
Official title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- varenicline (CP-526,555)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varenicline (CP-526,555)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
Secondary outcomes (6)
Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
4-week Point Prevalence of abstinence at Week 52
Long-Term Quit Rate at Weeks 24 and 52
Minnesota Nicotine Withdrawal Scale
Smoking Effects Inventory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 730 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143325
- Sponsor's protocol ID
- A3051044
- Status last verified
- Jun 2007
- First submitted
- 31 Aug 2005
- Last updated
- 4 Jun 2007
- Results posted
- No
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.
PubMed 18263663
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00143325
- Acronym / sponsor ID
- A3051044
- Conditions
- Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must have smoked an average of at least 15 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Key exclusion criteria (1 listed)
- Subjects with clinically significant cardiovascular disease in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| varenicline (CP-526,555) | Drug | – |
Primary outcome
Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
6 secondary outcomes
Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
4-week Point Prevalence of abstinence at Week 52
Long-Term Quit Rate at Weeks 24 and 52
Minnesota Nicotine Withdrawal Scale
Smoking Effects Inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2007.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 18263663Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing varenicline (CP-526,555) in people with Smoking Cessation, run by Pfizer at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Netherlands, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00143325, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2007.