"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
NCT01104636
Last updated date
ABOUT THIS STUDY
The aim of this study is to determine the success rates for stopping smoking with varenicline
in Germany. The main measure of success will be continuous abstinence from smoking (not a
single puff) in the last week of the standard 12 week treatment period. Additional
information will be gathered regarding prescribing practices in Germany, smoking history,
reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the
tolerability of varenicline.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Legal adult age
- Regular smoker, with main tobacco product smoked being cigarettes, and willing and motivated to stop smoking
- Evidence of a personally signed and dated Informed Consent document.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Any subjects considered unsuitable according to the Summary of product characteristics
(SmPC)
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | "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 | |||
| Official Title | "VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study | |||
| Brief Summary | The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline. | |||
| Detailed Description | Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Adult smokers who are willing and motivated to stop smoking | |||
| Condition | Smoking Cessation | |||
| Intervention | Drug: Varenicline
varenicline tablets prescribed as per local German SmPC for 12 weeks duration | |||
| Study Groups/Cohorts | Single group prospective treatment cohort (varenicline)
Intervention: Drug: Varenicline | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 1177 | |||
| Original Estimated Enrollment | 3000 | |||
| Actual Study Completion Date | March 2011 | |||
| Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01104636 | |||
| Other Study ID Numbers | A3051141 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2012 | |||