A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation.

Trial Profile

A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation.

Completed
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2013

At a glance

  • Drugs Nicotine abuse vaccine (Primary) ; Varenicline
  • Indications Smoking withdrawal; Substance-related disorders
  • Focus Therapeutic Use
  • Most Recent Events

    • 17 Oct 2012 Status changed from recruiting to completed based on information reported in a Nabi Biopharmaceuticals media release.
    • 17 Oct 2012 The primary endpoint, 'Treatment-success-rate' defined as the abstinence rate at 12 months, was not met according to a Nabi Biopharmaceuticals media release.
    • 17 Oct 2012 Results have been reported in a Nabi Biopharmaceuticals media release.
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