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 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
