PHASE 4, PROSPECTIVE, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SMOKING CESSATION WITH VARENICLINE TARTRATE COMPARED WITH PLACEBO IN THE SETTING OF PATIENT SELF-SELECTED (FLEXIBLE) QUIT DATE - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001497-33-IT
• Date of registration: 19/09/2008
• Prospective Registration: Yes
• Primary sponsor: PFIZER
• Public title: PHASE 4, PROSPECTIVE, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SMOKING CESSATION WITH VARENICLINE TARTRATE COMPARED WITH PLACEBO IN THE SETTING OF PATIENT SELF-SELECTED (FLEXIBLE) QUIT DATE - ND
• Scientific title: PHASE 4, PROSPECTIVE, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SMOKING CESSATION WITH VARENICLINE TARTRATE COMPARED WITH PLACEBO IN THE SETTING OF PATIENT SELF-SELECTED (FLEXIBLE) QUIT DATE - ND
• Date of first enrolment: 07/10/2008
• Target sample size: 652
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001497-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, France, Germany, Hungary, Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Current cigarette smokers, male or female, who are between the ages of 18 and 75 years, inclusive, and who are motivated to stop smoking. 2. Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year. 3. 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 of childbearing potential may be included provided that they are not pregnant, not nursing, and meet all of the following criteria: 4. Are instructed and agree to avoid pregnancy through 30 days after the last dose of study medication. 5. Have a negative serum pregnancy test (β-hCG) at screening; and. 6. Agree to use at least one of the birth control methods listed below: 7. An oral contraceptive, an Intrauterine Device (IUD), an implantable contraceptive, or an injectable contraceptive 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 drug or. 8. 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 drug. 9. Subjects must have no serious or unstable disease within the past 6 months (See exclusion criteria). 10. Subjects must be outpatients, assessed in a clinic setting and be able and willing to comply with all study visits , treatment plan, laboratory tests, and other trial procedures during the treatment and non-treatment phases. 11. Subjects must provide a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. 12. 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:
1. Subjects currently suffering with depression, or who have been diagnosed with depression or treated with an anti-depressant for their depression within the past 12 months. Subjects should be excluded if their score at the screening or baseline administration of the Patient Health Questionnaire (PHQ-9) is ≥5, or if they have a score of >0 on item 9 regarding suicidal ideation or behavior. 2. Subjects with any history of suicidal ideation or suicidal behavior as assessed by the Columbia Suicide-Severity Rating Scale (C-SSRS)(Baseline Version) in the past 5 years, or at the time of the Baseline Visit (since Last Visit version) 3. Subjects with a past or present history of psychosis; subjects with panic attacks or anxiety disorders; or bipolar disorder. 4. Subjects with known severe Chronic Obstructive Pulmonary Disease (COPD). 5. Subjects with clinically unstable cardiovascular disease in the past 6 months. Examples of clinically unstable cardiovascular diseases include myocardial infarction, Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant ECG conduction abnormalities (subjects with pacemakers may be included). 6. Subjects with a systolic blood pressure greater than 150 mmHg or a diastolic blood pressure greater than 95 mmHg at screening or baseline. 7. Subjects with clinically significant neurological disorders or cerebrovascular diseases (for example, stroke, transient ischemic attack, etc. with significant neurologic impairment in the past 6 months). 8. Subjects with a history of clinically significant or unstable endocrine disorders or gastrointestinal diseases, including insulin dependent diabetes, Type 2 diabetes mellitus with HgA1C ≥9, uncontrolled hyperthyroidism, and active peptic ulcer. 9. 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 severe abnormalities of renal function (estimated creatinine clearance by Cockcroft-Gault equation <30 mL/min) (Appendix 10). 10. Subjects with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed). 11. Subjects with evidence or history of serious or life-threatening allergic reactions to drugs (for example anaphylaxis or Stevens-Johnson syndrome). 12. Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months. 13. Subjects with a positive urine drug screen for drugs of abuse/potential abuse not prescribed for the treatment of a medical condition.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Varenicline is indicated as an aid to smoking cessation.
MedDRA version: 9.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy

Intervention(s)

Trade Name: Champix
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VARENICLINA
CAS Number: 375815-87-5
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: .5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Champix
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VARENICLINA
CAS Number: 375815-87-5
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is the 4-week continuous abstinence rate (CAR) for Weeks 9- 12 (ie, 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).

Main Objective: The primary efficacy objective of this protocol is to compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation in the setting of a patient selfselected quit date (before Week 5 visit), to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.

Secondary Objective: The safety objective is to gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up, and to evaluate safety and tolerability when used in the setting of a subject self-selected quit date.

Secondary ID(s)

A3051095

2008-001497-33-CZ