Smoking CessationPhase 3NCT00143286
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
A Phase 3 study testing varenicline (CP-526,555) in people with Smoking Cessation, run by Pfizer at 24 sites in 7 countries.
Trial summary
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52. 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
- 2,000 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Apr 2003to Mar 2005
- 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 10 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
24 sites in 7 countries.
24 sites in 7 countries
United States6 sites
Pfizer Investigational Site
Dallas, Texas
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Mogadore, Ohio
Pfizer Investigational Site
Santa Ana, California
Pfizer Investigational Site
Seattle, Washington
Pfizer Investigational Site
West Palm Beach, Florida
Canada6 sites
Pfizer Investigational Site
Calgary, Alberta
Pfizer Investigational Site
Cornwall, Prince Edward Island
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
Ottawa, Ontario
Pfizer Investigational Site
Sherbrooke, Quebec
Pfizer Investigational Site
Toronto, Ontario
Denmark3 sites
Pfizer Investigational Site
Aarhus C
Pfizer Investigational Site
Frederikssund
Pfizer Investigational Site
Hellerup, Copenhagen
Norway3 sites
Pfizer Investigational Site
Bergen
Pfizer Investigational Site
Hønefoss
Pfizer Investigational Site
Oslo
Sweden3 sites
Pfizer Investigational Site
Gothenburg
Pfizer Investigational Site
Helsingborg
Pfizer Investigational Site
Stockholm
United Kingdom2 sites
Pfizer Investigational Site
London, Surrey
Pfizer Investigational Site
London
About this study
Official title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
- 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 Weeks 13 -24.
Secondary outcomes (5)
Continuous abstinence Weeks 13-52
Long term quit rate at Week 52
7-day Point Prevalence of abstinence at Weeks 24, 52
4-week Point Prevalence of abstinence at Week 52
Time to first cigarette post randomization
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 startApr 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 2,000 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
- NCT00143286
- Sponsor's protocol ID
- A3051035
- 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 37142273Hajek P, Tonnesen P, Arteaga C, Russ C, Tonstad S. Varenicline in prevention of relapse to smoking: effect of quit pattern on response to extended treatment. Addiction. 2009 Sep;104(9):1597-602. doi: 10.1111/j.1360-0443.2009.02646.x.
PubMed 19686530Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
PubMed 16820548
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
- A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
- ClinicalTrials.gov ID
- NCT00143286
- Acronym / sponsor ID
- A3051035
- Conditions
- Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Mar 2005 (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.
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
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 10 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 Weeks 13 -24.
5 secondary outcomes
Continuous abstinence Weeks 13-52
Long term quit rate at Week 52
7-day Point Prevalence of abstinence at Weeks 24, 52
4-week Point Prevalence of abstinence at Week 52
Time to first cigarette post randomization
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 19686530Hajek P, Tonnesen P, Arteaga C, Russ C, Tonstad S. Varenicline in prevention of relapse to smoking: effect of quit pattern on response to extended treatment. Addiction. 2009 Sep;104(9):1597-602. doi: 10.1111/j.1360-0443.2009.02646.x.
- Derived from this study: PubMed 16820548Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
- 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
24 sites in 7 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 24 sites in 7 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 24 sites in United States, Canada, Denmark, Norway, Sweden and 2 more countries. 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 Weeks 13 -24.. 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 NCT00143286, which also lists 3 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.