Not Signed In -
Flexible Sigmoidoscopy |
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Clinical Trial: 12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
This study is no longer recruiting patients.
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Purpose
The purpose of the study is to measure the safety and efficacy of a flexible dosing strategy of CP-526,555 and placebo for smoking cessation.
| Condition | Intervention | Phase |
|---|---|---|
| Smoking cessation | Drug: Smoking Cessation | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 Mg to 2.0 Mg Total Daily Dose ) in Smoking Cessation
Further Study Details:
Primary Outcomes: The primary objective will be the measurement of the 4 week continuous quit rate at weeks 4-7 and 9 -12.
Secondary Outcomes: Continuous abstinence rate week 9-52 Results from the Minnesota Nicotine Withdrawal Scale Smoking Effects Inventory
Expected Total Enrollment: 300
Secondary Outcomes: Continuous abstinence rate week 9-52 Results from the Minnesota Nicotine Withdrawal Scale Smoking Effects Inventory
Expected Total Enrollment: 300
Study start: December 2001
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Subjects must have smoked an average of at least ten cigarettes per day during the past year
- No period of abstinence greater than three months in the past year
Exclusion Criteria:
- Subjects with history of clinically significant cardiovascular disease
- Subjects with uncontrolled hypertension.
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A3051016
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150228
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150228
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Flexible Sigmoidoscopy (National Institute of Diabetes and Digestive and Kidney Diseases)
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