Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-11 @ 1:02 AM
Study NCT ID:
NCT00995033
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2009-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: