The evaluation of the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers

Elan Corp (USA)0 个研究点目标入组 375 人开始时间: 2006年6月5日最近更新: 2015年1月13日

适应症

试验速览

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•1. Males or females motivated to quit smoking between the ages of 18 and 70 years
•2. Smoked at least 20 cigarettes a day for three years or more (smoking confirmed via expired CO level >10 ppm).
•All subjects had normal blood pressure and heart rate, weighed more than 100 pounds and typically no more than 130% of their ideal body weight, and expressed willingness to quit smoking on the specified target quit date (TQD). They were not currently using smokeless tobacco or other nicotine products. A detailed medical history, routine physical examination, laboratory tests and electrocardiogram (ECG) confirmed that subjects were in general good health. All women had a negative pregnancy test and agreed to use a medically accurate contraceptive method.

•Participants were excluded if they had a history of significant hepatic, renal, endocrine, cardiac, psychiatric, gastrointestinal, pulmonary, or metabolic disorder including hyperthyroidism, pheochromocytoma, diabetes, severe coronary insufficiency, recent myocardial infarction (within 90 days), glaucoma, cerebrovascular disease, stroke, chronic renal failure, prostatic hypertrophy, prostatic disease, bladder neck obstruction, urine retention, urethral stricture, a history of atopic or eczematous dermatitis, psoriasis, or altered skin condition at patch application site.

发起方

Elan Corp (USA)