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"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany (VIBRATIONS)

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ClinicalTrials.gov Identifier: NCT01104636
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 24, 2012
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Smoking Cessation
Intervention: Drug: Varenicline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1391 participants were screened and 1177 participants were assigned to the treatment.

Reporting Groups
  Description
Varenicline Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.

Participant Flow:   Overall Study
    Varenicline
STARTED   1177 
COMPLETED   999 
NOT COMPLETED   178 
Lack of Efficacy                43 
Lost to Follow-up                24 
Withdrawal by Subject                4 
Other                43 
Study terminated by sponsor                1 
Pregnancy                2 
Adverse Event                40 
Ongoing                21 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varenicline Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.

Baseline Measures
   Varenicline 
Overall Participants Analyzed 
[Units: Participants]
 1173 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 49.4  (12.0) 
[1] Demographic data for 4 participants was not available.
Gender, Customized [1] 
[Units: Participants]
 
Male   669 
Female   503 
Unspecified   1 
[1] Demographic data for 4 participants was not available.


  Outcome Measures

1.  Primary:   Percentage of Participants Who Abstained From Smoking at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Level of Nicotine Dependence Measured by the Fagerstrom Test   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01104636     History of Changes
Other Study ID Numbers: A3051141
First Submitted: April 14, 2010
First Posted: April 15, 2010
Results First Submitted: January 17, 2012
Results First Posted: February 24, 2012
Last Update Posted: March 2, 2012