EUCTR2005-004411-29-DE进行中（未招募）不适用
A 12-week, double-blind, placebo-controlled, multicenter study with a 40 week follow-up evaluating the safety and efficacy of Varenicline tartrate 1 mg BID for smoking cessation in subjects with cardiovascular disease - Not available
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 12 months and during the month prior to the Screening visit
- •6. Subjects must have stable, documented cardiovascular disease other than hypertension diagnosed >2 months prior to the Screening visit: Examples include:
- •Coronary Artery Disease demonstrated by:
- •Angina pectoris and evidence of abnormal myocardial perfusion or myocardial ischemia by stress testing or myocardial perfusion imaging or angina pectoris with positive coronary angiography. Test results or physician report must be provided.
- •Myocardial infarction documented by hospital summaries, procedure reports, laboratory reports, etc.
- •Coronary revascularization documented by physician or procedure report
- •Peripheral Vascular Disease demonstrated by:
- •Stable peripheral vascular disease (arterial) documented by history and physical exam (ankle-brachial index-ABI <0.9 but > 0.5), ultrasonography, arteriography. Subjects with asymptomatic carotid disease documented by imaging studies may be included
- •Peripheral revascularization documented by procedure report
- •Cerebrovascular Disease. For example, TIA or stroke without significant neurological impairment 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 of study 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 the last dose of study medication
- •abstinence
- •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
排除标准
- •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 for depression within the past 12 months
- •3. Subjects with a past or present history of psychosis, anxiety disorder, panic disorder, or bipolar disorder
- •4. Subjects, who in the judgement of the investigator, have moderate or severe chronic obstructive pulmonary disease (COPD) (see Appendix 1 for definitions of severity based on spirometry; however a study specific spirometry is not required. Subjects who have had a previous hospitalization for COPD should be excluded
- •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 (life threatening) arrhythmia, and clinically significant cardiac conduction abnormalities (> 1º AV block)
- •7. Subjects with uncontrolled hypertension or a systolic blood pressure greater than 160 mmHg or a diastolic blood pressure greater than 95 mmHg at the Screening or Baseline 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 or where the ankle-brachial index is =0.5.
- •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 creatinine clearance 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 screen for drugs of potential abuse and no medical indication for use of the drug.
- •15. 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, or nortriptyline within the past 1 month
- •21. Subjects who have participated in a study with an exper
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