Smoking Cessation MedDRA version: 8.0 Level: LLT Classification code 10053325
Conditions
Interventions
Product Name: Varenicline
Product Code: Not Applicable
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Varenicline Tartrate
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to be outpatients, to be assessed in a clinic setting, and be able and willing to comply with all study visits for 52 weeks during the treatment and non-treatment phases 2. Participating subjects must be able to provide written informed consent 3. Only one subject per household may participate 4. Subjects must be current cigarette smokers, male or female, who are between the ages of 35 and 75 years, inclusive, and who are motivated to stop smoking 5. Subjects must have smoked an average of at least 10 cigarettes per day during the past 12months and during the month prior to the Screening visit 6. Subjects must have stable, documented cardiovascular disease including at least one ofthe following diagnosed >2 months and 0.5), ultrasonography, arteriography. Subjects with asymptomatic carotid disease documented by imaging studies may be included •history of peripheral revascularization documented by procedure report •history of TIA documented by neurological evaluation, procedure report 7. Females who are not of childbearing potential (e.g., who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and meet all of the following criteria: •Are instructed and agree to avoid pregnancy through 30 days after the last dose ofstudy medication •Have a negative serum pregnancy test (ß -hCG) at screening •Agree to use at least one of the birth control methods listed below: •an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (for example, Norplant), or an injectable contraceptive (for example, Depo-Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication •a barrier method of contraception, for example, condom and/or diaphragm with spermicide while participating in the study through at least 30 days after thelast dose of study medication •abstinence 8. Subjects with diabetes under treatment by diet, exercise or medication and HgbA1C is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who have made a serious attempt to quit smoking in the past 3 months but have failed 2. Subjects currently suffering with depression, or who have been diagnosed with depression or treated with an anti-depressant within the past 12 months 3. Subjects with a past or present history of psychosis, panic disorder, or bipolar disorder 4. Subjects with moderate or severe chronic obstructive pulmonary disease (COPD) 5. Subjects with NYHA Class III or IV congestive heart failure 6. Subjects with unstable cardiovascular disease or cardiovascular events in the past 2 months. Examples include, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant cardiac conduction abnormalities (> 1º AV block) 7. Subjects with uncontrolled hypertension or a systolic blood pressure greater than160 mmHg or a diastolic blood pressure greater than 95 mmHg at the Screening orBaseline visit 8. Subjects with clinically significant neurological deficits related to cerebrovascular or other diseases, for example, stroke, etc. 9. Subjects with peripheral vascular disease (PVD) which has resulted in amputation 10. Subjects with a history of clinically significant endocrine disorders or gastrointestinal diseases that are uncontrolled, including uncontrolled hyperthyroidism, and active peptic ulcer disease 11. Subjects with clinically significant hepatic or renal impairment or other clinically significant abnormal laboratory test values: a. Subjects with an SGOT (AST) or SGPT (ALT) greater than 1.5 times the upper limit of normal (ULN) or total bilirubin greater than 1.1 times the ULN b. Subjects with severe abnormalities of renal function (estimated creatinineclearance by Cockcroft-Gault equation < 30mL/min) 12. Subjects with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed) 13. Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months 14. Subjects with a positive urine drug screen15. Subjects with a body mass index (BMI) less than 15 or greater than 38 when wearing indoor clothing without shoes. No subject will be enrolled with a weight less than 45.5 kg (100 pounds) 16. Subjects previously enrolled in a study that included varenicline (CP-526,555) 17. Subjects taking another investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline visit or within 30 days of completion of another study 18. Subjects taking a concomitant medication that is prohibited by this protocol 19. Subjects requiring other medications during the study that might interfere with the evaluation of the study drug (for example, nicotine replacement therapy, bupropion,clonidine, nortriptyline, or other medications used for smoking cessation including over the counter herbal remedies) 20. Subjects who have used a nicotine replacement product, bupropion, clonidine, ornortriptyline within the past 1 month 21. Subjects who have participated in a study with an experimental drug for smoking cessation within the past one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: The safety objective is to gather safety data in subjects with cardiovascular disease for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by a 40 week nontreatment follow-up period.; Main Objective: Main objective: The primary efficacy objective of this protocol is a comparison of 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation in subjects with cardiovascular disease and to evaluate continuous abstinence from smoking 40 weeks after the treatment period. ;Primary end point(s): The primary endpoint is the 4-week Continuous Quit Rate (CQR) for Weeks 9-12, i.e., the proportion of subjects who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled CO measurements =10 ppm, for the planned last 4 weeks of treatment. | — |
Countries
Czech Republic, Denmark, Germany, Greece, United Kingdom
Outcome results
None listed