NCT01574703 (CATS) is a Phase 4 clinical trial of varenicline tartrate in Smoking Cessation, sponsored by Pfizer.

Who is sponsoring NCT01574703?

NCT01574703 is sponsored by Pfizer.

What drugs are being tested in NCT01574703?

Interventions in NCT01574703: placebo, varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch.

What condition does NCT01574703 study?

NCT01574703 studies Smoking Cessation.

Is NCT01574703 still recruiting?

NCT01574703 is currently completed. Last updated 31 October 2016.

Are results published for NCT01574703?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-10-31 · How we verify

NCT01574703: CATS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders

Completed Phase 4 Results posted Last updated 31 October 2016

What this trial tests

Phase 4 trial testing placebo in Smoking Cessation in 4,595 participants. Completed in 1 July 2015.

Timeline

1 May 2012

Primary endpoint
1 July 2015

1 July 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Enrollment	4,595
Start date	1 May 2012
Primary completion	1 July 2015
Estimated completion	1 July 2015
Sites	134 locations across United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark

Drugs / interventions tested

placebo
varenicline tartrate — full drug profile →
bupropion hydrochloride — full drug profile →
Nicotine Replacement Therapy Patch

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. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.

Sponsor's own description

Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Nicotine receptor partial agonists for smoking cessation.
Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, et al · · 2016 · cited 228× · PMID 27158893 · DOI 10.1002/14651858.cd006103.pub7
Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial.
Benowitz NL, Pipe A, West R, Hays JT, et al · · 2018 · cited 85× · PMID 29630702 · DOI 10.1001/jamainternmed.2018.0397
Nicotine receptor partial agonists for smoking cessation.
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, et al · · 2023 · cited 62× · PMID 37142273 · DOI 10.1002/14651858.cd006103.pub8
Use of Contrave, Naltrexone with Bupropion, Bupropion, or Naltrexone and Major Adverse Cardiovascular Events: A Systematic Literature Review.
Dahlberg S, Chang ET, Weiss SR, Dopart P, et al · · 2022 · cited 8× · PMID 36200062 · DOI 10.2147/dmso.s381652
Nicotine receptor partial agonists for smoking cessation
Livingstone-Banks J, Fanshawe T, Thomas K, Theodoulou A, et al · · 2023

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01574703 (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: 31 October 2016

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/NCT01574703.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing