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Clinical trials for Asenapine

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   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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    25 result(s) found for: Asenapine. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2004-003340-22 Sponsor Protocol Number: A7501012 Start Date*: 2005-09-19
    Sponsor Name:Pfizer Luxembourg SARL Latvia Branch
    Full Title: A randomised, placebo controlled, double blind trial of asenapine in the prevention of relapse after long term treatment of schizophrenia.
    Medical condition: Schizophrenia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed)
    Trial results: View results
    EudraCT Number: 2010-018409-13 Sponsor Protocol Number: P05691 Start Date*: 2012-08-23
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering
    Full Title: A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experie...
    Medical condition: Bipolar 1 Disorder
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-022647-38 Sponsor Protocol Number: P06107 Start Date*: 2011-11-16
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated with Bipolar I Disorder (Protocol No. P06107)
    Medical condition: Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-018410-78 Sponsor Protocol Number: P05692 Start Date*: 2012-08-24
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering
    Full Title: A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed with Bipolar 1 Disorder who Completed Protocol P05691 (formerly 041044) (Phase3B,...
    Medical condition: Bipolar 1 Disorder
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-001472-12 Sponsor Protocol Number: A7501009 Amendment 1 Start Date*: 2006-04-12
    Sponsor Name:N V Organon
    Full Title: A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing Trial A7501008 and Continuing Lithium or Valproic Acid/Divalp...
    Medical condition: Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.0 10004939 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-001376-39 Sponsor Protocol Number: 25520 Start Date*: 2004-12-14
    Sponsor Name:NV Organon
    Full Title: Long-term efficacy and safety evaluation of asenapine (10-20 mg/day) in subjects with schizophrenia or schizoaffective disorder, in a multicenter trial using olanzapine (10-20 mg/day) as a control.
    Medical condition: schizophrenia or schizoaffective disorder
    Disease: Version SOC Term Classification Code Term Level
    7.0 10039628 HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2006-005585-40 Sponsor Protocol Number: A7501021 Start Date*: 2007-03-15
    Sponsor Name:NV Organon
    Full Title: A randomized, parallel group, multiple dose, 6 week study to evaluate safety, tolerability, and pharmacokinetics of asenapine in elderly subjects with psychosis.
    Medical condition: Acute and maintenance treatment of schizophrenia and manic episodes associated with bipolar I disorder.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039626 Schizophrenia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2010-022648-19 Sponsor Protocol Number: P05898 Start Date*: 2011-11-16
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: A 26-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed episodes Associated With Bipolar I Disorder
    Medical condition: Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-003927-11 Sponsor Protocol Number: A7501008 Start Date*: 2005-08-04
    Sponsor Name:NV Organon
    Full Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or ValproicAcid/Divalproex Sodium for the Treatment of...
    Medical condition: Bipolar 1 Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.0 10004939 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-018038-12 Sponsor Protocol Number: P05897 Start Date*: 2011-10-18
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: A 26-week, multi-center, open-label, flexible dose, long-term safety trial of asenapine in adolescent subjects with schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10039626 Schizophrenia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: RO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-017971-10 Sponsor Protocol Number: P05896 Start Date*: 2011-10-12
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: An 8-week, placebo-controlled, double-blind, randomized, fixed-dose efficacy and safety trial of asenapine in adolescent subjects with schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10039626 Schizophrenia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: RO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-018407-28 Sponsor Protocol Number: P05688 Start Date*: 2013-05-10
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering
    Full Title: A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine as an Active Control in Subjects With an Acute Ex...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-018408-96 Sponsor Protocol Number: P05689 Start Date*: 2013-06-12
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering
    Full Title: A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine using Olanzapine as an Active Control in Subjects Diagnosed with Schizophrenia who Completed Protocol...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-002169-35 Sponsor Protocol Number: 25544 Start Date*: 2005-12-27
    Sponsor Name:NV Organon
    Full Title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the safety and Efficacy of Asenapine With Olanzapine in Subjects who Completed Protocol 25543
    Medical condition: Schizophrenia with predominant, persistent negative symptoms
    Disease: Version SOC Term Classification Code Term Level
    7.1 10039626 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) ES (Completed) CZ (Completed) DE (Completed) HU (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-018671-20 Sponsor Protocol Number: P06384 Start Date*: 2012-08-24
    Sponsor Name:Forest Research Institute Inc., a wholly owned subsidiary of Forest Laboratories, LLC
    Full Title: A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phas...
    Medical condition: Bipolar 1 Disorder
    Disease: Version SOC Term Classification Code Term Level
    17.1 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2004-002560-17 Sponsor Protocol Number: 25543 Start Date*: 2005-04-14
    Sponsor Name:NV Organon
    Full Title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizop...
    Medical condition: Schizophrenia with predominant, persistent negative symptoms
    Disease: Version SOC Term Classification Code Term Level
    7.1 10039626 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Prematurely Ended) SE (Completed) DE (Completed) CZ (Completed) GB (Completed) IT (Completed) ES (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-005134-21 Sponsor Protocol Number: HP-3070-GL-04 Start Date*: 2016-07-01
    Sponsor Name:Noven Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, 6-Week, In-Patient Study to Assess Efficacy and Safety of HP-3070 in Subjects Diagnosed with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    18.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2012-000418-13 Sponsor Protocol Number: M10-855 Start Date*: 2012-12-21
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
    Medical condition: Cognitive Deficits in Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002213-19 Sponsor Protocol Number: ELICE-BD-O1 Start Date*: 2019-09-19
    Sponsor Name:University of British Columbia
    Full Title: A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Pa...
    Medical condition: Euthymic Bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003434-24 Sponsor Protocol Number: ACP-103-034 Start Date*: 2017-04-28
    Sponsor Name:ACADIA Pharmaceuticals Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) CZ (Completed) LT (Completed) PL (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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