Clinical trial NCT00808015: ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
Official title: ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Keywords: Observational non-interventional trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 1373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is in Asian patients. The patients enrolled should be of legal adult age who regularly smoke and whose main tobacco product is cigarettes. The patients must be willing to make an attempt to stop smoking.

Brief summary: The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in routine clinical practice.

Detailed description: Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.

Eligibility criteria: Inclusion Criteria:

* All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Exclusion Criteria:

* All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Primary outcomes:
measure: Percentage of Participants With Smoking Abstinence at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
timeFrame: Last observed study visit (Week 12 or early termination [ET])
measure: Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
timeFrame: Week 3 through Week 11
measure: CO Level at Last Observed Study Visit
timeFrame: Last observed study visit (Week 12 or ET)
measure: Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit
timeFrame: Last observed study visit (Week 12 or ET)
Other outcomes:
measure: Varenicline Prescription Status
timeFrame: After last observed study visit (Week 12 or ET)
measure: Average Daily Dose of Varenicline
timeFrame: Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)
measure: Median Duration of Treatment of Varenicline
timeFrame: Baseline through last observed study visit (Week 12 or ET)
measure: Concomitant Drug Treatments
timeFrame: Baseline through Last observed study visit (Week 12 or ET)
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Shenzhen
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Changsha
country: China
facility: Pfizer Investigational Site
state: Hunan
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shaanxi
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shaanxi
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shaanxi
city: Xian
country: China
facility: Pfizer Investigational Site
state: Shaanxi
city: Taiyuan
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Chengdu
country: China
facility: Pfizer Investigational Site
state: Sichuan
city: Tianjin
country: China
facility: Pfizer Investigational Site
state: Tianjin
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Nanning
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shijiazhuang
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
city: Wuhan
country: China
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Pfizer Investigational Site
state: Delhi
city: Ahmadabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Cochin
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Tthiruvananthapuram
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Daryaganj
country: India
facility: Pfizer Investigational Site
state: New Delhi
city: Delhi,
country: India
facility: Pfizer Investigational Site
state: New Delhi
city: Delhi
country: India
facility: Pfizer Investigational Site
state: New Delhi
city: Delhi
country: India
facility: Pfizer Investigational Site
state: New Delhi
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Pfizer Investigational Site
city: Delhi
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Cheonan-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Chungcheongnam-do
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeongnam
city: Iksan-Si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Jeollabuk-Do
city: Daegu-si
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon-Si
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Suwon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: San Juan
country: Philippines
facility: Pfizer Investigational Site
state: Batangas
city: Batac
country: Philippines
facility: Pfizer Investigational Site
state: Ilocos Norte
city: San Fernando City
country: Philippines
facility: Pfizer Investigational Site
state: La Union
city: Angeles City
country: Philippines
facility: Pfizer Investigational Site
state: Pampanga
city: Urdaneta City
country: Philippines
facility: Pfizer Investigational Site
state: Pangasinan
city: Tarlac City
country: Philippines
facility: Pfizer Investigational Site
state: Tarlac
city: Davao City
country: Philippines
facility: Pfizer Investigational Site
city: Marikina City
country: Philippines
facility: Pfizer Investigational Site
city: Pasay City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: