Partial nicotine agonist for use as an aid to smoking cessation. MedDRA version: 7.1 Level: LLT Classification code 10057852
Conditions
Interventions
Product Name: Varenicline Tartrate
Product Code: CP-526,555
Pharmaceutical Form: Tablet
INN or Proposed INN: Varenicline Tartrate
CAS Nu
Sponsors
Pfizer Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Current cigarette smokers, male or female, who are between the ages of 18 and 75 years,inclusive, and who are motivated to stop smoking. - Subjects must have smoked an average of at least 15 cigarettes per day during the past year and during the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. - Subjects with a weight more than 100 pounds (45.5 kg) and a body mass index (BMI) between 15 and 38 when wearing indoor clothing without shoes (see Appendix B). - Females who are not of childbearing potential (ie, 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 of study medication; . Have a negative serum pregnancy test -hCG) at screening and baseline; . Agree to use at least one of the birth control methods listed below: - an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (eg, Norplant), or an injectable contraceptive (eg, 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, eg, condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication; - abstinence. - Subjects must have no serious or unstable disease within the past 6 months. - 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 during the treatment and non-treatment phases. - Participating subjects must be able to provide written informed consent. - Only one subject per household may participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects currently suffering with depression, or who have been diagnosed with depression or treated with an anti-depressant within the past 12 months. - Subjects with a past or present history of psychosis, panic disorder, or bipolar disorder.- Subjects with severe chronic obstructive pulmonary disease (COPD). - Subjects with clinically significant cardiovascular disease in the past 6 months. - Subjects with uncontrolled hypertension or a systolic blood pressure greater than 150 mmHg or a diastolic blood pressure greater than 95 mmHg at screening or baseline. - Subjects with clinically significant neurological disorders or cerebrovascular diseases in the past 6 months. - Subjects with a history of clinically significant endocrine disorders or gastrointestinal diseases, including insulin dependent diabetes, uncontrolled hyperthyroidism, and active peptic ulcer. - Subjects with clinically significant hepatic or renal impairment or other clinically significant abnormal laboratory test values. - 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. - Subjects with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed). - Subjects with an allergy to adhesive tape or with skin disorders that may be exacerbated by NRT patch. - Subjects with evidence or history of clinically significant allergic reactions to drugs (eg, severe cutaneous and/or systemic allergic reactions) or any allergy to NRT. - Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months. - Subjects with a positive urine drug screen. - Subjects previously enrolled in a study that included varenicline (CP-526,555). - Subjects taking another investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline visit or within 30 days of study completion. - Subjects taking a concomitant medication that is prohibited by this protocol (see Section 5.4). - Subjects requiring other medications during the study that might interfere with the evaluation of the study drug - Subjects who have used a nicotine replacement product, bupropion, clonidine, or nortriptyline within the past 6 months, or have participated in a study with an experimental drug for smoking cessation within the past one year. - Subjects who do not agree to completely abstain from using non-cigarette tobacco products or marijuana during study participation. - Subjects who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of the study treatment. - Subjects unable and/or unlikely to comprehend and follow the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare Varenicline to NRT for smoking cessation efficacy at the end of 12 weeks of varenicline treatment and 10 weeks of NRT treatment, using the 4-week Continuous Quit Rate (CQR) as the primary measure. ; Secondary Objective: - Compare smoking cessation efficacy of 12 weeks varenicline and 10 weeks NRT treatment through the non-treatment follow-up periods to the end of Week 52. - Compare varenicline to NRT for treatment effects on craving, withdrawal and reward. - Evaluate safety of 12 weeks of varenicline treatment and 10 weeks of NRT treatment. ;Primary end point(s): The primary endpoint is the 4-week Continuous Quit Rate (CQR) at the end of the study treatment, ie, Week 12 visit for the varenicline group and Week 11 visit for the NRT group.Subjects will be classified as responders if they are able to maintain complete abstinence from cigarette smoking and other nicotine use (except NRT per protocol) for the last 4 weeks of treatment with end-expiratory exhaled CO measurements .10 ppm. | — |
Countries
United Kingdom
Outcome results
None listed