12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

Summary

The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.

Timeline

Start

2004-12

Primary completion

—

Completion

2006-02

Outcome

Met primary endpoint

paper The highest CAR of 65.4% (85/130) was achieved with varenicline 1 mg BID (odds ratio [OR] [95% CI] = 2.98 [1.78-4.99]; P < 0.001). PMID 17692720 ↗

Publications

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
• Nakamura M, Oshima A, Ohkura M, Arteaga C, Suwa K. Predictors of lapse and relapse to smoking in successful quitters in a varenicline post hoc analysis in Japanese smokers. Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5.
• Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012.

Drugs

Indications

No indication recorded.