Phase IIA Study in Patients With Schizophrenia

NCT ID: NCT00686998

Last Updated: 2013-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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This study is designed to assess the effects of AZD 2624 in patients with schizophrenia

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD2624

AZD2624 40 mg

Group Type EXPERIMENTAL

AZD2624

Intervention Type DRUG

Oral Suspension

Olanzapine

Olanzapine 15 mg

Group Type OTHER

Olanzapine

Intervention Type DRUG

PO BID

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD2624

Oral Suspension

Intervention Type DRUG

Olanzapine

PO BID

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Zyprexa

Eligibility Criteria

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Inclusion Criteria

* Females of non-childbearing potential
* Diagnosis of Schizophrenia

Exclusion Criteria

* Clinically relevant disease and /or abnormalities.
* Alcohol or substance abuse not in remission
* Enrollment in another investigational study within 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dhaval Desai, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Rockville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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D0970C00004

Identifier Type: -

Identifier Source: org_study_id

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