Smoking CessationPhase 4NCT00594204
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
A Phase 4 study testing varenicline tartrate (CP-526, 555-18) in people with Smoking Cessation, run by Pfizer at 42 sites in 11 countries.
Trial summary
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- varenicline tartrate (CP-526, 555-18)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 593 participants
- Where
- 42 sitesin 11 countries
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current male or female cigarette smokers who are motivated to stop smoking.
- Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.
Who cannot join
- Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
- Patients currently with depression or diagnosed with depression in past 12 months.
- Past or present history of psychosis, panic disorder, or bipolar disorder.
Trial locations and contacts
42 sites in 11 countries.
42 sites in 11 countries
South Africa13 sites
Pfizer Investigational Site
Benoni, Gauteng, 1501
Pfizer Investigational Site
Bloemfontein, Free State, 9300
Pfizer Investigational Site
Cape Town, Western Cape, 7764
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
Durban, 4091
Pfizer Investigational Site
Hillcrest, Pretoria, 0083
Pfizer Investigational Site
Lyttelton, 0140
Pfizer Investigational Site
Midrand, Gauteng, 1685
Pfizer Investigational Site
Paarl, Cape Town, Western Cape, 7647
Pfizer Investigational Site
Pretoria, Gauteng
Pfizer Investigational Site
Soweto, Johannesburg
Pfizer Investigational Site
Sydenham, Durban, KwaZulu-Natal, 4091
Pfizer Investigational Site
Tygerberg, Cape Town, 7505
Brazil7 sites
Pfizer Investigational Site
Botucatu, São Paulo, 18618-000
Pfizer Investigational Site
Fortaleza, Ceará, 60864-190
Pfizer Investigational Site
Juiz de Fora, Minas Gerais, 36036-110
Pfizer Investigational Site
Porto Alegre, Centro, RS
Pfizer Investigational Site
São Paulo, São Paulo, 04012-909
Pfizer Investigational Site
São Paulo, São Paulo, 04032-060
Pfizer Investigational Site
São Paulo, São Paulo, 05019-010
United Arab Emirates6 sites
Pfizer Investigational Site
Abu Dhabi
Pfizer Investigational Site
Al Ain City, 0
Pfizer Investigational Site
Dubai, United Arab Emirates, 0
Pfizer Investigational Site
Dubai, 0
Pfizer Investigational Site
Jumeirah/Dubai, 0
Pfizer Investigational Site
Ras Al Khaima, 0
Venezuela4 sites
Pfizer Investigational Site
Barquisimeto, Lara, 3002
Pfizer Investigational Site
Caracas, Distrito Federal, 1011
Pfizer Investigational Site
Caracas
Pfizer Investigational Site
Gran Caracas, Miranda, 1060
Mexico3 sites
Pfizer Investigational Site
México, D.f., 14000
Pfizer Investigational Site
Monterrey, Nuevo León, 64460
Pfizer Investigational Site
Morelia, Michoacán, 58249
Colombia2 sites
Pfizer Investigational Site
Barranquilla, Atlántico, 0
Pfizer Investigational Site
Medellín, Antioquia, 0
Lebanon2 sites
Pfizer Investigational Site
Beirut, Lebanon
Pfizer Investigational Site
Beirut Lebanon, Lebanon, 00000
Saudi Arabia2 sites
Pfizer Investigational Site
Jeddah, 21499
Pfizer Investigational Site
Riyadh, 11211
Costa Rica1 site
Pfizer Investigational Site
San Pedro, Provincia de San José
About this study
Official title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
- Conditions
- Smoking Cessation
- Being tested
- varenicline tartrate (CP-526, 555-18), Placebo
- 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 tartrate (CP-526, 555-18)Drug
Also called Chantix, Champix
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
PlaceboDrug
matching placebo 1 tablet twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Active comparator | Not described Receives: Drug: varenicline tartrate (CP-526, 555-18) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 4-week Continuous Abstinence
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits
Measured: Weeks 9 through 12
Secondary outcomes (2)
Number of Participants With Continuous Abstinence
The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm
Measured: Weeks 9 through 24
Number of Participants With Seven-day Point Prevalence of Abstinence
Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day
Measured: Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 593 participants (actual)
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
- NCT00594204
- Sponsor's protocol ID
- A3051080
- Status last verified
- Jul 2010
- First submitted
- 3 Jan 2008
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 37142273Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013.
PubMed 21635992
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
- ClinicalTrials.gov ID
- NCT00594204
- Acronym / sponsor ID
- A3051080
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 5 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Active comparator | Drug: varenicline tartrate (CP-526, 555-18) |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current male or female cigarette smokers who are motivated to stop smoking.
- Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.
Key exclusion criteria (3 listed)
- Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
- Patients currently with depression or diagnosed with depression in past 12 months.
- Past or present history of psychosis, panic disorder, or bipolar disorder.
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 tartrate (CP-526, 555-18)Also: Chantix, Champix1 mg twice a day for 12 weeks, starting with a 1-week titration period. | Drug | varenicline |
| Placebomatching placebo 1 tablet twice a day for 12 weeks | Drug | placebo |
Primary outcome
Number of Participants With 4-week Continuous Abstinence
Time frame: Weeks 9 through 12
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits
2 secondary outcomes
Number of Participants With Continuous Abstinence
Time frame: Weeks 9 through 24
Number of Participants With Seven-day Point Prevalence of Abstinence
Time frame: Week 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 21635992Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013.
- 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
42 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing varenicline tartrate (CP-526, 555-18) in people with Smoking Cessation, run by Pfizer at 42 sites in 11 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 2 inclusion and 3 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in South Africa, Brazil, United Arab Emirates, Venezuela, Mexico and 6 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With 4-week Continuous Abstinence (time frame: Weeks 9 through 12). 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 NCT00594204, 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 20 Jul 2010.