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Trial record 1 of 1 for:    NCT00686998
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Phase IIA Study in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00686998
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : June 23, 2011
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AZD2624 Drug: Olanzapine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AZD2624
AZD2624 40 mg
Drug: AZD2624
Oral Suspension
Olanzapine
Olanzapine 15 mg
Drug: Olanzapine
PO BID
Other Name: Zyprexa
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline [ Time Frame: Baseline, Day 28 ]
    PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00686998


Locations
United States, Maryland
Research Site
Rockville, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dhaval Desai, MD AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00686998     History of Changes
Other Study ID Numbers: D0970C00004
First Posted: May 30, 2008    Key Record Dates
Results First Posted: June 23, 2011
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents