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Seroquel Sustained Release

Phase 3

Schizophrenic Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Trials Updated: Jan 4, 2013

Seroquel Sustained Release target and mechanism

ModalitySmall molecule

Also known as Seroquel Sustained Release (SR)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment535

FDA Designations

No designations recorded

Seroquel Sustained Release clinical trials

Seroquel Sustained Release · 1 trial · 1 indication

Phase 3 1
NCT00206115SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With SchizophreniaSchizophrenic Disorder
COMPLETED535 Analytics
PHASE3COMPLETED
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
Schizophrenic DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.

Secondary Endpoints

Efficacy
To demonstrate a higher PANSS response rate
To demonstrate superior Clinical Global Impressions (CGI) response
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Seroquel Sustained Release (SR)DRUG -
Seroquel Immediate Release (IR)DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate. Exclusion Criteria: * Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and d...

Countries:BulgariaGreeceIndiaIndonesiaPhilippinesRomaniaRussiaSouth Africa
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Frequently asked questions about Seroquel Sustained Release

What is Seroquel Sustained Release?

Seroquel Sustained Release is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for the treatment of schizophrenic disorder. It is a sustained release formulation studied in a Phase 3 registration trial. It is also known as Seroquel Sustained Release (SR).

What is Seroquel Sustained Release used for?

Seroquel Sustained Release is being studied for the treatment of schizophrenic disorder. Its clinical development has focused on this psychiatric indication, with a Phase 3 registration study conducted in patients with schizophrenia. It is not described as approved for any use.

Who makes Seroquel Sustained Release?

Seroquel Sustained Release is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 3 registration study of the sustained release formulation in schizophrenia.

What phase is Seroquel Sustained Release in?

Seroquel Sustained Release is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and has not been described as approved by the FDA.

What clinical trials is Seroquel Sustained Release in?

Seroquel Sustained Release has been studied in one completed Phase 3 trial, NCT00206115, titled SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel in the Treatment of Patients With Schizophrenia. The randomized, double-blind study enrolled 535 patients across Bulgaria, Greece, India, Indonesia, the Philippines, Romania, Russia, and South Africa.

Is Seroquel Sustained Release the same as Seroquel SR?

Yes. Seroquel Sustained Release and Seroquel SR refer to the same AstraZeneca product, with SR standing for sustained release. Both names describe the sustained release formulation studied in the Phase 3 schizophrenia program.