Study to assess the efficacy, safety, and tolerability of AZD8529 in adult schizophrenia patients
Study identifier:D1960C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
schizophrenia
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD 8529, Risperidone, Placebo to match AZD8529, Placebo to match AZD8529, Placebo to match risperidone, Placebo to match risperidone
Sex
All
Actual enrollment
152
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 May 2010
Study Completion Date: 01 May 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD8529 40 mg | Drug: AZD 8529 40mg oral daily capsule administered as a single dose in the morning for 28 days 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 |
| Placebo Comparator: 2 Placebo | 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 |
| Other: 3 Risperidone 4 mg (2mg on Day 1) | Drug: Risperidone 4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days Other Name: 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 |
Contacts
Investigators
Principal Investigator
Robert , Litman
CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850
