Back to resultsPhase IIA Study in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD2624
Olanzapine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Placebo Comparator
Arm Label
AZD2624
Olanzapine
Placebo
Arm Description
AZD2624 40 mg
Olanzapine 15 mg
Matching Placebo
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00686998
Brief Title
Phase IIA Study in Patients With Schizophrenia
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD2624
Arm Type
Experimental
Arm Description
AZD2624 40 mg
Arm Title
Olanzapine
Arm Type
Other
Arm Description
Olanzapine 15 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
AZD2624
Intervention Description
Oral Suspension
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
PO BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
Description
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.
Time Frame
Baseline, Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhaval Desai, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase IIA Study in Patients With Schizophrenia
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