E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057852 |
E.1.2 | Term | Nicotine dependence |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy, safety, and tolerability of varenicline compared with placebo in adolescent smokers aged 12-19 years. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Healthy male and female subjects between the ages of 12 and 19 years inclusive (at screening), who are motivated to stop smoking.
• Subjects must be currently smoking at least an average of 5 cigarettes per day and have a Fagerstrom Test for Nicotine Dependence total score of 4 or higher.
• Subjects must have had at least one prior failed attempt to quit smoking.
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E.4 | Principal exclusion criteria |
• Subjects with current evidence or history of clinically significant psychiatric disease (in the past year).
• Subjects with a prior suicide attempt, subjects hospitalized within the past twelve months due to suicidal ideation or suicidal behavior, or subjects considered to have had serious suicidal ideation or suicidal behavior within the past twelve months, active suicidal ideation or behavior identified at the screening or baseline visits.
• Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
4-week continuous abstinence rate (CAR) from Week 9 through Week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- 7-day point-prevalence of smoking abstinence at Week 12.
- 7-day point-prevalence of smoking abstinence at Week 24.
- 7-day point-prevalence of smoking abstinence at Week 52.
- Reduction in number of cigarettes smoked at Week 12.
- Reduction in number of cigarettes smoked at Week 24.
- Reduction in number of cigarettes smoked at Week 52.
- Continuous abstinence rate from Week 9 through Week 24.
- Continuous abstinence rate from Week 9 through Week 52. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Week 12
- Week 24
- Week 52
- Week 12
- Week 24
- Week 52
- Week 9 through Week 24
- Week 9 through Week 52 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Subjects received up to 10 minutes of age-appropriate smoking cessation counselling at each visit. |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Canada |
Georgia |
Korea, Republic of |
Russian Federation |
Taiwan |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 5 |