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Trial record 63 of 64 for:    brexpiprazole

A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

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ClinicalTrials.gov Identifier: NCT04002700
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.

Condition or disease Intervention/treatment
Stroke Drug: Haloperidol Drug: Typical Antipsychotics Drug: Atypical Antipsychotics

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Study Type : Observational
Actual Enrollment : 1234412 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Haloperidol

Group/Cohort Intervention/treatment
Target Cohort 1
Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis.
Drug: Typical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study.

Target Cohort 2
Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis.
Drug: Haloperidol
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study.

Target Cohort 3
Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (>=) 65 years.
Drug: Typical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study.

Target Cohort 4
Participants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year.
Drug: Haloperidol
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study.

Target Cohort 5
Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years.
Drug: Typical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study.

Target Cohort 6
Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years.
Drug: Haloperidol
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study.

Comparator Cohort 7
Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis.
Drug: Atypical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study.

Comparator Cohort 8
Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years.
Drug: Atypical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study.

Comparator Cohort 9
Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years.
Drug: Atypical Antipsychotics
Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study.




Primary Outcome Measures :
  1. Number of Participants with Stroke as a Principal Inpatient Diagnosis [ Time Frame: Up to 16 years (from 01-January-2002 through 31-December-2017) ]
    Number of participants with stroke in each target cohort versus comparator cohort (aged 65 years and older) per person years at risk will be reported. It is defined defined by the presence of the relevant ICD codes (ICD-9 or ICD-10 according to date) in the inpatient setting as the primary diagnoses.


Secondary Outcome Measures :
  1. Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics [ Time Frame: Up to 16 years (from 01-January-2002 through 31-December-2017) ]
    The number of participants with the risk of stroke among participants exposed to typical antipsychotics versus atypical antipsychotics will be reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population is the participants in (any of) the target or comparator cohorts. Each target and comparator cohort will be drawn from the appropriate database: IBM MarketScan Commercial Database (CCAE) if the participants are aged 18-64 years and IBM MarketScan Medicare Supplemental Database (MDCR) if participants are aged greater than or equal to (>=) 65 years.
Criteria

Inclusion Criteria:

For entry event of an initial drug exposure:

  • First exposure to the particular drug(s) in the past 183 days (index date)
  • Had at least 183 days of continuous observation time prior to index
  • Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date
  • Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date
  • Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002700


Locations
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United States, New Jersey
Janssen Investigative Site
Titusville, New Jersey, United States, 08560
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04002700     History of Changes
Other Study ID Numbers: CR108624
PCSESP001292 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antipsychotic Agents
Haloperidol
Haloperidol decanoate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents