A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers
Phase of Trial: Phase IV
Latest Information Update: 05 Jul 2018
At a glance
- Drugs Varenicline (Primary)
- Indications Smoking withdrawal
- Focus Therapeutic Use
- Sponsors Pfizer
- 01 May 2018 The study is a regulatory post-marketing commitment for Chantix/Champix in the U.S. and the European Union (EU) for adolescents 12-16 years and 12-17 years of age, respectively. As part of planned regulatory interactions in the U.S. and EU, these data will be submitted to the U.S. Food and Drug Administration (FDA) for pediatric exclusivity determination.
- 29 Mar 2018 New trial record
- 23 Mar 2018 According to a Pfizer media release, company announce a topline results from this study.