A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
NCT00150241
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Adult Trials: 18+ Years
- Subjects must have smoked on average of at least ten cigarettes per day during the past year
- Subjects must have no period of abstinence greater than three months in the past year
- Subjects with any history of cardiovascular disease
- Myocardial infarction
- Significant arrhythmias
- Poorly controlled hypertension
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation | |||
| Official Title ICMJE | A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation | |||
| Brief Summary | The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Smoking Cessation | |||
| Intervention ICMJE | Drug: CP-526,555 (varenicline) | |||
| Study Arms ICMJE | Not Provided | |||
| 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 ICMJE | Completed | |||
| Enrollment ICMJE | 625 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | January 2002 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00150241 | |||
| Other Study ID Numbers ICMJE | A3051002 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||