EFFICACY AND SAFETY OF SMOKING CESSATION WITH VARENICLINE TARTRATE IN DIBETIC SMOKERS: A DOUBLE-BLIND,PLACEBO-CONTROLLED, RANDOMIZED, TRIAL - ND

• Conditions: diabetic smokers

• Registration Number: EUCTR2009-017599-26-IT
• Lead Sponsor: CENTRO PER LA PREVENZIONE E CURA DEL TABAGISMO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-22
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Type 2 diabetic patients (≤ 75 years of age) who are regular smokers (10 cigs/day during the past year, with no period of abstinence greater than three months in the past year) and willing to quit. 2. Females of nonchildbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception. 3. Participating subjects must be able to provide written informed consent.
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

1. Subjects currently or within the past 12 months requiring treatment for depression. Subjects with a past or present history of panic disorder, psychosis, or bipolar disorder; 2. Subjects with a current or recent (within the past 12 months) history of alcoholism; 3. Subjects with a requirement to use other medications during the study that might interfere with the evaluation of the study drug (e.g., nicotine replacement therapy); 4. Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing indoor clothing without shoes and determined using the Body Mass Index (BMI); 5. Subjects with evidence or history of clinically significant allergic (except for seasonal allergies at time of dosing), endocrine, gastrointestinal, hematological, hepatic, neurologic, pulmonary, or renal disease or a history of cancer (excluding treated basal cell carcinoma and squamous cell carcinoma). Exceptions to this exclusion may include subjects with a history of mild chronic obstructive pulmonary disease, and stable thyroid disease. 6. Subjects with a history of clinically significant cardiovascular disease. In addition, subjects with uncontrolled hypertension or a screening or baseline systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified