Last reviewed · How we verify
NCT00143325
An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Phase 3 trial testing varenicline (CP-526,555) in Smoking Cessation in 730 participants. Completed in 1 June 2006.
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 730 |
| Start date | 1 January 2005 |
| Estimated completion | 1 June 2006 |
| Sites | 22 locations across United States, Belgium, France, Netherlands, United Kingdom |
Drugs / interventions tested
- varenicline (CP-526,555) — 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.
- Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
Sponsor's own description
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial.
Aubin HJ, Bobak A, Britton JR, Oncken C, et al · · 2008 · cited 207× · PMID 18263663 · DOI 10.1136/thx.2007.090647
Verify or expand the search:
- PubMed search for NCT00143325
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 NCT00143325 (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: 1 June 2007
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/NCT00143325.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing