ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking

NCT00808015 | Completed Results

• 1 other identifier: A3051112
• Study Type: observational
• Target: 1,373
• Locations: 4 countries
• Sites: 97

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.

Conditions

Smoking Cessation

Keywords

Observational non-interventional trial

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Smoking Abstinence at Week 12

  Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.

  Week 12

Secondary Outcomes (4)

• Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit

  Last observed study visit (Week 12 or early termination [ET])

• Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11

  Week 3 through Week 11

• CO Level at Last Observed Study Visit

  Last observed study visit (Week 12 or ET)

• Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit

  Last observed study visit (Week 12 or ET)

Other Outcomes (4)

• Varenicline Prescription Status

  After last observed study visit (Week 12 or ET)

• Average Daily Dose of Varenicline

  Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)

• Median Duration of Treatment of Varenicline

  Baseline through last observed study visit (Week 12 or ET)

Study Arms (1)

Patients in routine practice

Patients prescribed Champix by treating physician and then entered into trial

Drug: varenicline

Interventions

varenicline DRUG

Champix will be prescribed as per usual practice and at the sole discretion of the physician

Also known as: Champix, Chantix

Patients in routine practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (97)

Pfizer Investigational Site

Beijing, Beijing Municipality, 100029, China

Location

Pfizer Investigational Site

Beijing, Beijing Municipality, 100083, China

Location

Pfizer Investigational Site

Beijing, Beijing Municipality, 100191, China

Location

Pfizer Investigational Site

Guangzhou, Guangdong, 510080, China

Location

Pfizer Investigational Site

Guangzhou, Guangdong, 510150, China

Location

Pfizer Investigational Site

Guangzhou, Guangdong, 510515, China

Location

Pfizer Investigational Site

Shenzhen, Guangdong, 518020, China

Location

Pfizer Investigational Site

Wuhan, Hubei, 430060, China

Location

Pfizer Investigational Site

Changsha, Hunan, 410006, China

Location

Pfizer Investigational Site

Nanjing, Jiangsu, 210009, China

Location

Pfizer Investigational Site

Suzhou, Jiangsu, 215004, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110000, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110016, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110024, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110042, China

Location

Pfizer Investigational Site

Xi'an, Shaanxi, 710004, China

Location

Pfizer Investigational Site

Xi'an, Shaanxi, 710032, China

Location

Pfizer Investigational Site

Xi'an, Shaanxi, 710038, China

Location

Pfizer Investigational Site

Xi'an, Shaanxi, 710068, China

Location

Pfizer Investigational Site

Taiyuan, Shanxi, 030012, China

Location

Pfizer Investigational Site

Chengdu, Sichuan, 610041, China

Location

Pfizer Investigational Site

Tianjin, Tianjin Municipality, 300192, China

Location

Pfizer Investigational Site

Beijing, 100020, China

Location

Pfizer Investigational Site

Beijing, 100029, China

Location

Pfizer Investigational Site

Beijing, 100036, China

Location

Pfizer Investigational Site

Beijing, 100038, China

Location

Pfizer Investigational Site

Beijing, 100039, China

Location

Pfizer Investigational Site

Beijing, 100045, China

Location

Pfizer Investigational Site

Beijing, 100050, China

Location

Pfizer Investigational Site

Beijing, 100091, China

Location

Pfizer Investigational Site

Beijing, 100096, China

Location

Pfizer Investigational Site

Beijing, 100730, China

Location

Pfizer Investigational Site

Beijing, 100853, China

Location

Pfizer Investigational Site

Nanning, 530021, China

Location

Pfizer Investigational Site

Shanghai, 200025, China

Location

Pfizer Investigational Site

Shanghai, 200031, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

Pfizer Investigational Site

Shanghai, 200040, China

Location

Pfizer Investigational Site

Shanghai, 200065, China

Location

Pfizer Investigational Site

Shanghai, 200072, China

Location

Pfizer Investigational Site

Shanghai, 200080, China

Location

Pfizer Investigational Site

Shanghai, 200233, China

Location

Pfizer Investigational Site

Shanghai, 200433, China

Location

Pfizer Investigational Site

Shanghai, 201203, China

Location

Pfizer Investigational Site

Shijiazhuang, 050011, China

Location

Pfizer Investigational Site

Tianjin, 300051, China

Location

Pfizer Investigational Site

Tianjin, 300162, China

Location

Pfizer Investigational Site

Tianjin, 300280, China

Location

Pfizer Investigational Site

Wuhan, 430022, China

Location

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500029, India

Location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380005, India

Location

Pfizer Investigational Site

Kochi, Kerala, 682026, India

Location

Pfizer Investigational Site

Tthiruvananthapuram, Kerala, 695504, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 022, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 070, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400008, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400036, India

Location

Pfizer Investigational Site

Delhi, National Capital Territory of Delhi, 110088, India

Location

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, 110 076, India

Location

Pfizer Investigational Site

Daryāganj, New Delhi, 110 002, India

Location

Pfizer Investigational Site

Delhi, New Delhi, 110017, India

Location

Pfizer Investigational Site

Delhi, New Delhi, 110027, India

Location

Pfizer Investigational Site

Delhi, New Delhi, 110085, India

Location

Pfizer Investigational Site

New Delhi, New Delhi, 110 016, India

Location

Pfizer Investigational Site

Coimbatore, Tamil Nadu, 641045, India

Location

Pfizer Investigational Site

Chennai, 600 032, India

Location

Pfizer Investigational Site

San Juan City, Batangas, Philippines

Location

Pfizer Investigational Site

Batac, Ilocos Norte, 2906, Philippines

Location

Pfizer Investigational Site

San Fernando City, La Union, 2500, Philippines

Location

Pfizer Investigational Site

Angeles City, Pampanga, Philippines

Location

Pfizer Investigational Site

Urdaneta, Pangasinan, Philippines

Location

Pfizer Investigational Site

Tarlac City, Tarlac, Philippines

Location

Pfizer Investigational Site

Davao City, 8000, Philippines

Location

Pfizer Investigational Site

Marikina City, Philippines

Location

Pfizer Investigational Site

Pasay, 1301, Philippines

Location

Pfizer Investigational Site

Quezon City, 1100, Philippines

Location

Pfizer Investigational Site

Quezon City, 1103, Philippines

Location

Pfizer Investigational Site

Quezon City, Philippines

Location

Pfizer Investigational Site

Cheonan-si, Chungcheongnam-do, 330-715, South Korea

Location

Pfizer Investigational Site

Goyang-si, Gyeonggi-do, 411-719, South Korea

Location

Pfizer Investigational Site

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Pfizer Investigational Site

Suwon, Gyeonggi-do, 442-723, South Korea

Location

Pfizer Investigational Site

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Pfizer Investigational Site

Iksan-Si, Jeollabuk-do, 570-711, South Korea

Location

Pfizer Investigational Site

Daegu, 700-712, South Korea

Location

Pfizer Investigational Site

Daegu, 705-717, South Korea

Location

Pfizer Investigational Site

Daegu, 705-718, South Korea

Location

Pfizer Investigational Site

Daejeon, 301-721, South Korea

Location

Pfizer Investigational Site

Daejeon, 301-804, South Korea

Location

Pfizer Investigational Site

Incheon, 403-720, South Korea

Location

Pfizer Investigational Site

Incheon, 405-760, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Seoul, South Korea

Location

Pfizer Investigational Site

Suwon, 443-721, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Outcome measures were not designated as primary or secondary measures as this study was a post-marketing, prospective, non-comparative and non-interventional study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 12, 2015
• Results First Posted: July 28, 2011

Record last verified: 2015-04

Locations

IN (17); CN (49); PH (12); KR (19)