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Phase IIA Study in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686998
First received: May 28, 2008
Last updated: March 20, 2013
Last verified: March 2013
History of Changes

May 28, 2008
March 20, 2013
May 2008
March 2009   (final data collection date for primary outcome measure)
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
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.
Change in PANSS total score [ Time Frame: From baseline to Day 28 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00686998 on ClinicalTrials.gov Archive Site
Not Provided
  • Safety and Tolerability of AZD2624 vs Placebo [ Time Frame: Assessed throughout study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic evaluation [ Time Frame: overall-28 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase IIA Study in Patients With Schizophrenia
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

This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: AZD2624
    Oral Suspension
  • Drug: Olanzapine
    PO BID
    Other Name: Zyprexa
  • Drug: Placebo
  • Experimental: AZD2624
    AZD2624 40 mg
    Intervention: Drug: AZD2624
  • Olanzapine
    Olanzapine 15 mg
    Intervention: Drug: Olanzapine
  • Placebo Comparator: Placebo
    Matching Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00686998
D0970C00004
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Dhaval Desai, MD AstraZeneca
AstraZeneca
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP