NCT00691483

A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

Completed Phase 4 Results posted Last updated 16 October 2015

What this trial tests

Phase 4 trial testing placebo in Smoking Cessation in 659 participants. Completed in 1 December 2009.

Timeline

1 September 2008

Primary endpoint
1 September 2009

1 December 2009

Quick facts

Lead sponsor	Pfizer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	659
Start date	1 September 2008
Primary completion	1 September 2009
Estimated completion	1 December 2009
Sites	33 locations across United States, Argentina, Brazil, Canada, China, Czechia, France, Germany

Drugs / interventions tested

• placebo
• 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.

• Percentage of Participants With 4-week Continuous Abstinence (CA)
  Time frame: Week 9 through Week 12
  The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \>10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visi

Sponsor's own description

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Publications & conference data

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

1. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates.
   Rennard S, Hughes J, Cinciripini PM, Kralikova E, et al · · 2012 · cited 66× · PMID 22080588 · DOI 10.1093/ntr/ntr220
2. 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