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IR quetiapine

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jun 11, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

IR quetiapine · 1 trial · 1 indication

Phase 2 1
NCT00254787Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic PatientsSchizophrenia
COMPLETED30 Analytics
PHASE2COMPLETED
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment

Secondary Endpoints

Safety and Tolerability
Number and type of adverse events
Changes in vital signs and weight
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
IR (Immediate-Release) quetiapine fumarate (drug)DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Men and women age ≥18 to ≤65 years with acute schizophrenia * Provision of written informed consent prior to enrolment Exclusion Criteria: * Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder ...

Countries:Germany
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Frequently asked questions about IR quetiapine

What is IR quetiapine used for?

IR quetiapine is an investigational small molecule being studied for the treatment of schizophrenia. It is an immediate-release formulation of quetiapine, a psychiatry medication. As of the available data, it is in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes IR quetiapine?

IR quetiapine is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with schizophrenia.

What phase is IR quetiapine in?

IR quetiapine is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for marketing. The drug is being studied for the treatment of schizophrenia, and its development is ongoing.

What clinical trials is IR quetiapine in?

IR quetiapine has one completed clinical trial, identified by the National Clinical Trial number NCT00254787. This Phase 2 study, titled "Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients," enrolled 30 participants in Germany. The trial was randomized and double-blind, though it did not use a control group.

Is IR quetiapine FDA approved?

IR quetiapine is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for the treatment of schizophrenia. The drug has not completed the clinical development process required for regulatory approval, and its safety and efficacy have not been fully established.