Trial | NCT00921804  Report issue

Title

Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    azd8529 risperidone ...

  • Study Participants

    296
The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.
Study Started
Jun 30
2009
Primary Completion
May 31
2010
Study Completion
May 31
2010
Last Update
Jun 30
2010
Estimate

Drug AZD 8529

40mg oral daily capsule administered as a single dose in the morning for 28 days

Drug Risperidone

4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days

  • Other names: Risperdal

Drug Placebo to match AZD8529

Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period

Drug Placebo to match risperidone

Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period

1 Experimental

AZD8529 40 mg

2 Placebo Comparator

Placebo

3 Other

Risperidone 4 mg (2mg on Day 1)

Criteria 

Inclusion Criteria:

Patient will need to read, understand and sign an informed consent prior to any study specific procedures
Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry

Exclusion Criteria:

Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
Patients will be excluded if urine drug screen test show positive results
Smoking of more than 2 packs of cigarettes a day
No Results Posted