|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00143325 |
|
Date of registration:
|
31/08/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
|
|
Scientific title:
|
An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation |
|
Date of first enrolment:
|
January 2005 |
|
Target sample size:
|
730 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00143325 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Belgium
|
France
|
Netherlands
|
United Kingdom
|
United States
| | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Subjects must have smoked an average of at least 15 cigarettes per day during the
past year and over the month prior to the screening visit, with no period of
abstinence greater than 3 months in the past year.
Exclusion Criteria:
- Subjects with clinically significant cardiovascular disease in the past 6 months.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Smoking Cessation
|
|
Intervention(s)
|
|
Drug: varenicline (CP-526,555)
|
|
Primary Outcome(s)
|
|
Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
|
|
Secondary Outcome(s)
|
|
7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
|
|
Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
|
|
Long-Term Quit Rate at Weeks 24 and 52
|
|
4-week Point Prevalence of abstinence at Week 52
|
|
Minnesota Nicotine Withdrawal Scale
|
|
Smoking Effects Inventory
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|