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Clinical trials for varenicline AND Placebo

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44398   clinical trials with a EudraCT protocol, of which   7410   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    26 result(s) found for: varenicline AND Placebo. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-021789-31 Sponsor Protocol Number: A3051139 Start Date*: 2010-12-08
    Sponsor Name:Pfizer Inc.235 East 42nd Street, New York, NY 10017 US
    Full Title: A PHASE 4 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF RE-TREATMENT WITH VARENICLINE IN SUBJECTS WHO ARE CURRENTLY SMOKING, AND WHO HAVE PRE...
    Medical condition: Smoking Cessation
    Disease: Version SOC Term Classification Code Term Level
    15.0 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-006426-34 Sponsor Protocol Number: 1705480563 Start Date*: 2009-03-06
    Sponsor Name:Pulmonary dept. Gentofte Hospital
    Full Title: Varenicline for long-term nicotine replacement therapy (NRT) users A double blind, placebo controlled trial
    Medical condition: Long-term dependence of nicotine substitution products (gum, inhaler, sublingual, spay)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-000546-31 Sponsor Protocol Number: A3051104 Start Date*: 2008-07-16
    Sponsor Name:Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ
    Full Title: A RANDOMIZED, MULTICENTRE, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY OF VARENICLINE IN CESSATION OF ORAL TOBACCO USE
    Medical condition: Cessation of oral smokeless tobacco use in current non-smokers.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053325 Smoking cessation therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001530-34 Sponsor Protocol Number: PPVMvhH/146-2011/MvhH Start Date*: 2012-08-09
    Sponsor Name:VU University Medical Center [...]
    1. VU University Medical Center
    2. Center Human Drug Research
    Full Title: Varenicline, a partial nicotinic receptor agonist for the treatment of Excessive Daytime Sleepiness in Parkinson’s Disease: a placebo-controlled cross-over study
    Medical condition: Idiopathic Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-004412-70 Sponsor Protocol Number: A3051054 Start Date*: 2007-07-25
    Sponsor Name:PFIZER
    Full Title: A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL WITH 40-WEEK FOLLOW-UP EVALUATING THE SAFETY AND EFFICACY OF VARENICLINE TARTRATE FOR SMOKING CESSATION IN PATIENTS WIT...
    Medical condition: Smoking Cessation
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001767-30 Sponsor Protocol Number: A3051070 Start Date*: 2007-07-27
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States
    Full Title: PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE MULTIPLE-DOSE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF VARENICLINE IN HEALTHY ADOLESCENT SMOKERS
    Medical condition: Smoking cessation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053325 Smoking cessation therapy LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Not Authorised) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001357-14 Sponsor Protocol Number: KUM_PSY_2017_1 Start Date*: 2017-09-28
    Sponsor Name:Klinikum der Universität München - AöR verteten durch den Vorstand des Bereiches Humanmedizin
    Full Title: Randomized, doubleblind, 4-arms, monocentric, interventinal Study for enhancing the efficacy of tDCS across from single intervention or Placebo by nicotinergic stimulation in schizophrenia.
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10040707 Simple type schizophrenia, chronic state LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017599-26 Sponsor Protocol Number: WS508648 Start Date*: 2010-01-12
    Sponsor Name:CENTRO PER LA PREVENZIONE E CURA DEL TABAGISMO
    Full Title: EFFICACY AND SAFETY OF SMOKING CESSATION WITH VARENICLINE TARTRATE IN DIBETIC SMOKERS: A DOUBLE-BLIND,PLACEBO-CONTROLLED, RANDOMIZED, TRIAL
    Medical condition: diabetic smokers
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000048-24 Sponsor Protocol Number: COMB-BO8 Start Date*: 2018-12-28
    Sponsor Name:Sahlgrenska University Hospital/VGR
    Full Title: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER TRIAL ON THE EFFICACY OF VARENICLINE AND BUPROPION, IN COMBINATION AND ALONE, FOR THE TREATMENT OF ALCOHOL USE DISORDER
    Medical condition: Alcohol Use Disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001497-33 Sponsor Protocol Number: A3051095 Start Date*: 2008-10-02
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full 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 SEL...
    Medical condition: SMOKING CESSATION
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053325 Smoking cessation therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) DE (Completed) IT (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-004411-29 Sponsor Protocol Number: A3051049 Start Date*: 2006-01-16
    Sponsor Name:
    Full Title: A 12-week, double-blind, placebo-controlled, multicenter study with a 40 week follow-up evaluating the safety and efficacy of Varenicline tartrate 1 mg BID for smoking cessation in subjects with ca...
    Medical condition: Smoking Cessation
    Disease: Version SOC Term Classification Code Term Level
    8.0 10053325 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) CZ (Completed) DE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000339-42 Sponsor Protocol Number: W1206810 Start Date*: 2016-08-29
    Sponsor Name:CENTRO PER LA PREVENZIONE E CURA DEL TABAGISMO
    Full Title: Efficacy of smoking cessation with varenicline for e-cigarettes users: a randomized controlled trial (VAREVAPE)
    Medical condition: problems related to the use of nicotine
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10068678 Nicotine abuse LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021788-33 Sponsor Protocol Number: A3051075 Start Date*: 2011-07-13
    Sponsor Name:Pfizer Inc.235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 4, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VARENICLINE COMPARED TO PLACEBO FOR SMOKING CESSATION THROUGH REDUCTION
    Medical condition: Smoking Cessation
    Disease: Version SOC Term Classification Code Term Level
    15.0 10041244 - Social circumstances 10008374 Cessation of smoking LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-000761-37 Sponsor Protocol Number: A3051073 Start Date*: 2018-03-23
    Sponsor Name:Pfizer, Inc.
    Full Title: 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 Ado...
    Medical condition: NICOTINE DEPENDENCE
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10057852 Nicotine dependence PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-003588-37 Sponsor Protocol Number: P150952J Start Date*: 2018-05-09
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: A randomized, placebo controlled, double blind, double dummy, multicenter trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine
    Medical condition: Smokers smoking at least 10 cigarettes/day in the past year
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-004692-36 Sponsor Protocol Number: VAR/01/011 Start Date*: 2011-11-30
    Sponsor Name:HOSPITAL UNIVERSITARI DE BELLVITGE
    Full Title: COMBIVAR. Randomized double-blind trial of two parallel groups design to evaluate the efficacy of smoking cessation with combined (varenicline plus nicotine patches) versus monotherapy (varenicline)
    Medical condition: NICOTINE DEPENDENCE.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10032707 Other specified drug dependence, continuous use LLT
    14.0 10037175 - Psychiatric disorders 10012336 Dependence addictive LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005894-36 Sponsor Protocol Number: ZonMw61200014/Nabi4508 Start Date*: 2009-04-27
    Sponsor Name:ZonMw [...]
    1. ZonMw
    2. nabi biopharmaceuticals
    Full Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm Study to Assess Efficacy and Safety of 3’-aminomethylnicotine-P. aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or placebo,...
    Medical condition: Smoking: Subjects must be smoking an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 mont...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053325 Smoking cessation therapy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-014916-37 Sponsor Protocol Number: A3051122 Start Date*: 2010-03-15
    Sponsor Name:PFIZER
    Full Title: "Estudio de fase 4, doble ciego, controlado con placebo, multicéntrico y de 12 semanas de duración para evaluar la seguridad y la eficacia del tartrato de Vareniclina (CP-526,555) 1 mg dos veces a...
    Medical condition: "Dejar de Fumar" "Smoking cessation"
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053325 Smoking cessation therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2010-022914-15 Sponsor Protocol Number: A3051123 Start Date*: 2012-03-01
    Sponsor Name:Pfizer, S.L.U.
    Full Title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO -CONTROLLED, MULTICENTER STUDY EVALUATING THE NEUROPSYCHIATRIC SAFETY AND EFFICACY OF 12 WEEKS VARENICLINE TARTRATE 1MG BID AND BUPROPION HYD...
    Medical condition: Nicotine Addiction with the desire to quit smoking
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) DK (Completed) FI (Completed) BG (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2011-005513-37 Sponsor Protocol Number: A3051148 Start Date*: 2012-07-25
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US
    Full Title: A PHASE 4, NON-TREATMENT FOLLOW-UP FOR CARDIAC ASSESSMENTS FOLLOWING USE OF SMOKING CESSATION TREATMENTS IN SUBJECTS WITH AND WITHOUT A HISTORY OF PSYCHIATRIC DISORDERS
    Medical condition: Nicotine Addiction with the desire to quit smoking
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FI (Completed) BG (Completed) DK (Completed) SK (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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