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NCT00141167
A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation
Phase 3 trial testing varenicline in Smoking Cessation in 250 participants. Completed in 1 January 2006.
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 1 February 2005 |
| Estimated completion | 1 January 2006 |
| Sites | 10 locations across South Korea, Taiwan |
Drugs / interventions tested
- varenicline (varenicline) — full drug profile →
Conditions studied
- Smoking Cessation — all drugs for Smoking Cessation →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 75, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
Sponsor's own description
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interventions for preventing weight gain after smoking cessation.
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, et al · · 2021 · cited 40× · PMID 34611902 · DOI 10.1002/14651858.cd006219.pub4 -
Varenicline in smokers with diabetes: A pooled analysis of 15 randomized, placebo-controlled studies of varenicline.
Tonstad S, Lawrence D. · · 2017 · cited 27× · PMID 27223809 · DOI 10.1111/jdi.12543
Verify or expand the search:
- PubMed search for NCT00141167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of varenicline
Trials testing the same drug.
- NCT07145866 — Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study) · Phase 4 · not yet recruiting
- NCT02854800 — Smoking Cessation & Opioid Dependence Treatment Integration · Phase 2, PHASE3 · completed
- NCT01771627 — Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers · NA · completed
- NCT01290445 — Varenicline Pregnancy Cohort Study · completed
- NCT00781755 — Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal · Phase 4 · withdrawn
Other recruiting trials for Smoking Cessation
Currently open trials in the same condition.
- NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
- NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients · Phase 1 · recruiting
- NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer · NA · recruiting
- NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors · NA · recruiting
- NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting
Other Pfizer trials
Trials by the same sponsor.
- NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
- NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
- NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
- NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
- NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00141167 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 3 September 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00141167.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing