Clinical Trials/NCT00921804

NCT00921804

Completed

Phase 2

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

AstraZeneca1 site in 1 country296 target enrollmentJune 2009

ConditionsSchizophrenia

InterventionsAZD 8529 Placebo to match risperidone Placebo to match AZD8529 Risperidone

DrugsAZD 8529 Risperidone Placebo to match AZD8529 Placebo to match risperidone

Overview

Phase: Phase 2
Intervention: AZD 8529
Conditions: Schizophrenia
Sponsor: AstraZeneca
Enrollment: 296
Locations: 1
Primary Endpoint: PANSS Total Score
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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

Arms & Interventions

1

AZD8529 40 mg

Intervention: AZD 8529

1

AZD8529 40 mg

Intervention: Placebo to match risperidone

2

Placebo

Intervention: Placebo to match AZD8529

2

Placebo

Intervention: Placebo to match risperidone

3

Risperidone 4 mg (2mg on Day 1)

Intervention: Risperidone

3

Risperidone 4 mg (2mg on Day 1)

Intervention: Placebo to match AZD8529

Outcomes

Primary Outcomes

PANSS Total Score

Time Frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28

Secondary Outcomes

PANSS Positive, Negative, and General Psychopathology Subscale Scores(Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28)
CGI-S(Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28)
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events(Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28)