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Immediate release Paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

Clinical trial landscape

Immediate release Paliperidone · 1 trial · 2 indications

Phase 1 1
NCT00791349A Study of QT and QTc Intervals in Patients Administered Immediate Release PaliperidoneSchizophrenia
COMPLETED141 Analytics
PHASE1COMPLETED
A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the cardiovascular safety of paliperidone in schizophrenic or schizoaffective patients, with particular attention to the length of the QT/QTc interval. Other ECG parameters, such as QRS and PR intervals, will also be carefully measured

Secondary Endpoints

To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Immediate release (IR) PaliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must have a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV criteria, with no exacerbation of psychosis for at least 3 months prior to screening * Patients must have a normal 12-lead ECG at screening and on Day -1, including: Normal sinus r...

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Frequently asked questions about Immediate release Paliperidone

What is Immediate Release Paliperidone used for?

Immediate Release Paliperidone is an investigational small molecule being studied for the treatment of schizophrenia. It is currently in Phase 1 clinical development. The drug is being developed by Johnson & Johnson (JNJ) for use in psychiatry.

Who makes Immediate Release Paliperidone?

Immediate Release Paliperidone is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development for schizophrenia.

What phase is Immediate Release Paliperidone in?

Immediate Release Paliperidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed for this candidate.

What clinical trials is Immediate Release Paliperidone in?

Immediate Release Paliperidone has been studied in one completed Phase 1 clinical trial, NCT00791349, titled 'A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone'. The trial enrolled 141 participants with schizophrenia or schizoaffective disorder.

Is Immediate Release Paliperidone the same as Paliperidone?

Immediate Release Paliperidone is a specific formulation of the drug paliperidone. The 'immediate release' designation refers to how the medication is released in the body, as opposed to extended-release versions. This formulation is being studied for schizophrenia.