- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01312909
Smoking Cessation Study In Healthy Adolescent Smokers
12 lipca 2018 zaktualizowane przez: Pfizer
A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
312
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Moscow, Federacja Rosyjska, 119331
- GBUZ City childrens out-patient clinic # 10 of Moscow
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Murmansk, Federacja Rosyjska, 183036
- GOBUZ Murmansk Regional Narcology Dispensary
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Novosibirsk, Federacja Rosyjska, 630091
- LLC City Neurological Center "Sibneuromed"
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Saint-Petersburg, Federacja Rosyjska, 190068
- LLC " Alliance Biomedical - Russian Group"
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Saint-Petersburg, Federacja Rosyjska, 191025
- LLC Medical Technologies
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Saint-Petersburg, Federacja Rosyjska, 192019
- FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
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Saint-Petersburg, Federacja Rosyjska, 192148
- LLC Medical Technologies
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Saint-Petersburg, Federacja Rosyjska, 197022
- First St. Petersburg State Medical University
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Samara, Federacja Rosyjska, 443031
- GBUZ Samara Regional Childrens Health camp Yunost
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Leningrad Region
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Village Novoe Devyatkino, Leningrad Region, Federacja Rosyjska, 188661
- Leningrad Regional Dispensary of Narcology
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Rustavi, Gruzja, 3700
- LTD" Rustavi Psychological Health Center"
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Ontario
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Ajax, Ontario, Kanada, L1Z 0M1
- Kids Clinic
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New Market, Ontario, Kanada, L3Y 5G8
- SKDS Research Inc.
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Newmarket, Ontario, Kanada, L3Y 5G8
- Private Practice of Robert J. Camargo
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Daegu, Republika Korei, 41931
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Republika Korei, 14068
- Hallym University Sacred Heart Hospital
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Seongnam-si, Gyeonggi-do, Republika Korei, 13620
- Seoul National University Bundang Hospital
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Suwon-si, Gyeonggi-do, Republika Korei, 442 723
- The Catholic University of Korea St. Vincent Hospital
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Alabama
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Ozark, Alabama, Stany Zjednoczone, 36360
- IICR, Inc. (DBA: International Institute of Clinical Research)
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Arizona
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Goodyear, Arizona, Stany Zjednoczone, 85395
- Dedicated Clinical Research
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72211
- Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
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California
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Anaheim, California, Stany Zjednoczone, 92801
- Anaheim Clinical Trials, LLC
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La Habra, California, Stany Zjednoczone, 90631
- Omega Clinical Trials, LLC
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National City, California, Stany Zjednoczone, 91950
- Synergy Clinical Research Center
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Oakland, California, Stany Zjednoczone, 94607
- Pacific Research Partners, LLC
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Oceanside, California, Stany Zjednoczone, 92054
- North County Clinical Research
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- University of Colorado Anschutz Medical Campus
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Colorado Springs, Colorado, Stany Zjednoczone, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Stany Zjednoczone, 80209
- Western Affiliated Research Institute
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06520
- Yale University
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New Haven, Connecticut, Stany Zjednoczone, 06511
- Connecticut Mental Health Center
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New Haven, Connecticut, Stany Zjednoczone, 06511
- Yale University, SATU
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Florida
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DeLand, Florida, Stany Zjednoczone, 32720
- Avail Clinical Research, LLC
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Kissimmee, Florida, Stany Zjednoczone, 34741
- HOPE Clinical Research
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Maitland, Florida, Stany Zjednoczone, 32751
- Florida Clinical Research Center, LLC
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Miami, Florida, Stany Zjednoczone, 33126
- Pharmax Research Clinic, Inc.
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Miami, Florida, Stany Zjednoczone, 33144
- L & L Research Choices
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North Bay Village, Florida, Stany Zjednoczone, 33141
- Bravo Health Care Center
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Orange City, Florida, Stany Zjednoczone, 32763
- Medical Research Group of Central Florida
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Saint Petersburg, Florida, Stany Zjednoczone, 33716
- Comprehensive Clinical Development Inc.
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Idaho
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Meridian, Idaho, Stany Zjednoczone, 83646
- Solaris Clinical Research
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Meridian, Idaho, Stany Zjednoczone, 83646
- Barney Greenspan, Ph.D
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Indiana
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Evansville, Indiana, Stany Zjednoczone, 47715
- Midwest Behavioral Health
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Indianapolis, Indiana, Stany Zjednoczone, 46260
- Goldpoint Clinical Research, LLC
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Newburgh, Indiana, Stany Zjednoczone, 47630
- Pedia Research, LLC
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Kansas
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Wichita, Kansas, Stany Zjednoczone, 67207
- Heartland Research Associates, LLC
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Kentucky
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Bardstown, Kentucky, Stany Zjednoczone, 40004
- Kentucky Pediatric/Adult Research
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Lexington, Kentucky, Stany Zjednoczone, 40509
- Central Kentucky Research Associates, Inc.
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Owensboro, Kentucky, Stany Zjednoczone, 42301
- Pedia Research, LLC
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Owensboro, Kentucky, Stany Zjednoczone, 42303
- Research Integrity, LLC
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70114
- Louisiana Research Associates, Inc
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Massachusetts
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Watertown, Massachusetts, Stany Zjednoczone, 02472
- Adams Clinical Trials, LLC
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Michigan
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Rochester Hills, Michigan, Stany Zjednoczone, 48307
- Rochester Center for Behavioral Medicine
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64114
- The Center for Pharmaceutical Research, P.C.
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O'Fallon, Missouri, Stany Zjednoczone, 63368
- Psychiatric Care & Research Center
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Saint Louis, Missouri, Stany Zjednoczone, 63109
- Mid-America Clinical Research, LLC
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Nebraska
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Lincoln, Nebraska, Stany Zjednoczone, 68526
- Premier Psychiatric Research Institute, LLC
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North Carolina
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Raleigh, North Carolina, Stany Zjednoczone, 27612
- Wake Research Associates
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Raleigh, North Carolina, Stany Zjednoczone, 27612
- Wake Internal Medicine Consultants, Inc
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Wilmington, North Carolina, Stany Zjednoczone, 28401
- PMG Research of Wilmington, LLC
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Ohio
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Canton, Ohio, Stany Zjednoczone, 44718
- Neuro-Behavioral Clinical Research, Inc.
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Toledo, Ohio, Stany Zjednoczone, 43623
- Neurology & Neuroscience Center Of Ohio
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73116
- Cutting Edge Research Group
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425
- Medical University of South Carolina
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Mount Pleasant, South Carolina, Stany Zjednoczone, 29464
- Coastal Carolina Research Center
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Texas
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Dallas, Texas, Stany Zjednoczone, 75231
- FutureSearch Trials of Dallas, L.P.
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DeSoto, Texas, Stany Zjednoczone, 75115
- InSite Clinical Research, LLC
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Lake Jackson, Texas, Stany Zjednoczone, 77566
- R/D Clinical Research, Inc.
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San Antonio, Texas, Stany Zjednoczone, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Stany Zjednoczone, 78230
- Thomas Murray DeMoor, MD
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Virginia
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Richmond, Virginia, Stany Zjednoczone, 23235
- Clinical Research Partners, LLC
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Washington
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Kirkland, Washington, Stany Zjednoczone, 98033
- Eastside Therapeutic Resource
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Richland, Washington, Stany Zjednoczone, 99352
- Zain Research, Llc
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Wisconsin
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Middleton, Wisconsin, Stany Zjednoczone, 53562
- Dean Foundation for Health Research and Education
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Kaohsiung City, Tajwan, 81362
- Kaohsiung Veterans General Hospital
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New Taipei City, Tajwan, 220
- Far Eastern Memorial Hospital
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New Taipei City, Tajwan, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung city, Tajwan, 40447
- China Medical University Hospital
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Tainan, Tajwan, 704
- National Cheng Kung University Hospital
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Taipei City, Tajwan, 11217
- Taipei Veterans General Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
12 lat do 19 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Healthy male and female subjects between the ages of 12 and 19, inclusive.
- Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
- Subjects must have at least one prior failed attempt to quit smoking.
Exclusion Criteria:
- Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
- Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
- Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
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Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
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Eksperymentalny: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
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Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
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Komparator placebo: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
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Oral placebo for twelve weeks,follow-up through Week 52
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Ramy czasowe: Week 9 through Week 12
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The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
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Week 9 through Week 12
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Ramy czasowe: Weeks 12, 24 and 52
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The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.
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Weeks 12, 24 and 52
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Daily Number of Cigarettes Smoked at Baseline
Ramy czasowe: Baseline
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The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
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Baseline
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Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
Ramy czasowe: Baseline, Weeks 12, 24, and 52
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The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
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Baseline, Weeks 12, 24, and 52
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Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
Ramy czasowe: Week 9 through Week 24; Week 9 through Week 52
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The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.
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Week 9 through Week 24; Week 9 through Week 52
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs)
Ramy czasowe: First dose up to last dose (up-to Week 12) plus 30 days
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
AEs included both non-serious AEs and SAEs.
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First dose up to last dose (up-to Week 12) plus 30 days
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Ramy czasowe: First dose up to last dose (up-to Week 12) plus 30 days
|
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Relatedness to drug Varenicline was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category were counted once within the category.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs included both non-serious AEs and SAEs.
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First dose up to last dose (up-to Week 12) plus 30 days
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Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)
Ramy czasowe: First dose up to last dose (up-to Week 12) plus 30 days
|
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly.
Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation.
If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.
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First dose up to last dose (up-to Week 12) plus 30 days
|
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Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Ramy czasowe: Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
|
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of "Yes" on "actual attempt");preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior","aborted attempt" or "interrupted attempt"),suicidal ideation ("Yes" on "wish to be dead","non-specific active suicidal thoughts","active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").Here,number of participants with positive response (response of "yes") to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported.
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Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points
Ramy czasowe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
|
The HADS is a self-administered questionnaire measuring anxiety.
Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety.
Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.
|
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points
Ramy czasowe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
|
Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression.
Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.
|
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
|
|
Number of Participants With Laboratory Abnormalities
Ramy czasowe: Baseline up to Week 12
|
Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.
|
Baseline up to Week 12
|
|
Change From Baseline in Blood Pressure (BP) at Week 12
Ramy czasowe: Baseline, Week 12
|
Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP.
Blood pressure was taken after participants rested in a sitting position for 5 minutes.
BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.
|
Baseline, Week 12
|
|
Change From Baseline in Pulse Rate at Week 12
Ramy czasowe: Baseline, Week 12
|
Measurement of pulse rate included supine, sitting and standing pulse rate.
Pulse rate was taken after participants rested in a sitting position for 5 minutes.
Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.
|
Baseline, Week 12
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
- Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 kwietnia 2011
Zakończenie podstawowe (Rzeczywisty)
1 stycznia 2018
Ukończenie studiów (Rzeczywisty)
1 stycznia 2018
Daty rejestracji na studia
Pierwszy przesłany
9 marca 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 marca 2011
Pierwszy wysłany (Oszacować)
11 marca 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
9 sierpnia 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 lipca 2018
Ostatnia weryfikacja
1 lipca 2018
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- A3051073
- CHANTIX (Inny identyfikator: Alias Study Number)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Varenicline 1mg BID
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Dr. Falk Pharma GmbHZakończonyEozynofilowe zapalenie przełykuNiemcy
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SOM Innovation Biotech SAZakończonyPląsawica HuntingtonaHiszpania
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VivaCell Biotechnology EspañaJeszcze nie rekrutacjaChoroba tętnic obwodowychHiszpania
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Kanion & Huawe Medicine Co.,LtdZakończony
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Haisco Pharmaceutical Group Co., Ltd.ZakończonyObwodowy ból neuropatycznyChiny
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PfizerZakończony
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AstraZenecaZakończonyChoroba ParkinsonaStany Zjednoczone