A Comparison of Study Drug With Placebo and Haloperidol i... | NCT00044044 | Trialant
NCT00044044
Sponsor
Sumitomo Pharma America, Inc.
Status
Completed
Last Update Posted
Apr 17, 2014Estimated
Enrollment
356Actual
Phase
Phase 2
Conditions
Schizophrenia
Interventions
Lurasidone 20 mg
Lurasidone 40mg
Lurasidone 80 mg
Haloperidol 10mg
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00044044
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D1050049
Secondary IDs
Not provided
Brief Title
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Official Title
A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
Acronym
Not provided
Organization
Sumitomo Pharma America, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2002
Primary Completion Date
May 2003Actual
Completion Date
May 2003Actual
First Submitted Date
Aug 16, 2002
First Submission Date that Met QC Criteria
Aug 19, 2002
First Posted Date
Aug 20, 2002Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 1, 2011
Results First Submitted that Met QC Criteria
Mar 11, 2011
Results First Posted Date
Apr 12, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 31, 2014
Last Update Posted Date
Apr 17, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sumitomo Pharma America, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Detailed Description
Not provided
Conditions Module
Conditions
Schizophrenia
Keywords
Schizophrenia
Latuda
Lurasidone
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
356Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Lurasidone 20 mg
Experimental
Lurasidone 20 mg tablets
Drug: Lurasidone 20 mg
Lurasidone 40 mg
Experimental
Lurasidone 40 mg tablets
Drug: Lurasidone 40mg
Lurasidone 80 mg
Experimental
Lurasidone 2 40 mg tablets
Drug: Lurasidone 80 mg
Haloperidol 10mg
Active Comparator
Haloperidol 10mg tablets
Drug: Haloperidol 10mg
Placebo
Placebo Comparator
Matching Placebo to Lurasidone and Haloperidol
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lurasidone 20 mg
Drug
Lurasidone 20mg/day tablets
Lurasidone 20 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Baseline and 6 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
The patient has a primary diagnosis of schizophrenia
The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
The patient has had a duration of illness of at least one year.
The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
The patient is able to remain off antipsychotic medication for a 4 day washout period
Exclusion criteria:
The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline
Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
20 mg
Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
FG001
40 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Lurasidone 40mg
Drug
Lurasidone 40mg/day tablets
Lurasidone 40 mg
Lurasidone 80 mg
Drug
Lurasidone 80mg/day - 2 40mg tablets
Lurasidone 80 mg
Haloperidol 10mg
Drug
Haloperidol 10mg/day tablets
Haloperidol 10mg
Placebo
Drug
Matching Placebo to Lurasdione and Haloperidol
Placebo
Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Baseline and 6 weeks
Cerritos
California
90703
United States
CNS Network
Garden Grove
California
92845
United States
California Clinical Trials Medical Group
Glendale
California
91206
United States
Optimum Health Services
La Mesa
California
91942
United States
University of California, Irvine
Orange
California
92868
United States
Affiliated Research Institute
San Diego
California
92108
United States
Sharp Mesa Vista Hospital
San Diego
California
92123
United States
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego
California
92126
United States
Comprehensive Neuroscience. Inc.
Washington D.C.
District of Columbia
20016
United States
Comprehensive Neuroscience. Inc.
Melbourne
Florida
32935
United States
Segal Institute for Clinical Research
North Miami
Florida
33161
United States
University of South Florida
Tampa
Florida
33613
United States
Coordinated Research of Florida, Inc.
Winter Park
Florida
32789
United States
Atlanta Center for Medical Research
Atlanta
Georgia
30308
United States
Carman Research
Smyrna
Georgia
30080
United States
Hawaii Research Center
Honolulu
Hawaii
96826
United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates
Illinois
60194
United States
American Medical Research
Oak Brook
Illinois
60523
United States
Centers for Behavioral Health, LLC
Rockville
Maryland
20850
United States
Lake Mead Hospital
North Las Vegas
Nevada
89030
United States
Comprehensive Clinical Research CNS, PC
Clementon
New Jersey
08021
United States
ClinSearch, Inc.
Kenilworth
New Jersey
07033
United States
Psychiatric Professional Services Inc
Cincinnati
Ohio
45267
United States
Quantum Clinical Services Group
Philadelphia
Pennsylvania
19139
United States
Albert Einstein Medical Center - Dept. of Psychiatry
Philadelphia
Pennsylvania
19141
United States
Community Clinical Research
Austin
Texas
78756
United States
FutureSearch Trials
Austin
Texas
78756
United States
Claghorn Lesem Research Clinic, Inc.
Bellaire
Texas
77401
United States
St. Paul Medical Center
Dallas
Texas
75235
United States
University Hills Clinical Research
Dallas
Texas
75235
United States
CNS, Inc.
Falls Church
Virginia
22041
United States
Northwest Clinical Research Center
Belleview
Washington
98004
United States
Medstream, Inc.
Milwaukee
Wisconsin
53210
United States
Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
FG002
80 mg
Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
FG003
10 mg Haloperidol
10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
FG004
Placebo
Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
FG00071 subjects
FG00169 subjects
FG00271 subjects
FG00373 subjects
FG00472 subjects
COMPLETED
FG00027 subjects
FG00128 subjects
FG00231 subjects
FG00329 subjects
FG00436 subjects
NOT COMPLETED
FG00044 subjects
FG00141 subjects
FG00240 subjects
FG00344 subjects
FG00436 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
20 mg
Lurasidone 20 mg oral tablet taken once a day
BG001
40 mg
Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
BG002
80 mg
Lurasidone 80 mg oral tablet taken once a day
BG003
10 mg Haloperidol
10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
BG004
Placebo
Oral Capsule matching treatment group taken oce a day
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00071
BG00167
BG00271
BG00372
BG00472
BG005353
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.7± 10.5
BG00142.0± 10.9
BG00242.2± 8.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00121
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Posted
Jan 2011
Least Squares Mean
Standard Error
units on a scale
Baseline and 6 weeks
ID
Title
Description
OG000
20 mg
Lurasidone 20 mg oral tablet taken once a day
OG001
40 mg
Lurasidone 40 mg oral tablet taken once a day
OG002
80 mg
Lurasidone 80 mg oral tablet taken once a day
OG003
10 mg Haloperidol
10 mg Haloperidol overencapsulated tablet taken orally once a day
OG004
Placebo
Oral Capsule matching treatment group taken oce a day
Units
Counts
Participants
OG00071
OG00165
OG00270
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.0± 1.38
OG001-5.2± 1.44
OG002-8.0± 1.40
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
ANCOVA
<0.05
2-Sided
95
No
Superiority or Other
Secondary
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Posted
Jan 2011
Least Squares Mean
Standard Error
units on a scale
Baseline and 6 weeks
ID
Title
Description
OG000
20 mg
Lurasidone 20 mg oral tablet taken once a day
OG001
40 mg
Lurasidone 40 mg oral tablet taken once a day
OG002
80 mg
Lurasidone 80 mg oral tablet taken once a day
OG003
Secondary
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Posted
Jan 2011
Least Squares Mean
Standard Error
units on a scale
Baseline and 6 weeks
ID
Title
Description
OG000
20 mg
Lurasidone 20 mg oral tablet taken once a day
OG001
40 mg
Lurasidone 40 mg oral tablet taken once a day
OG002
80 mg
Lurasidone 80 mg oral tablet taken once a day
OG003
10 mg Haloperidol
Secondary
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.
Posted
Jan 2011
Least Squares Mean
Standard Error
units on scale
Baseline and 6 weeks
ID
Title
Description
OG000
20 mg
Lurasidone 20 mg oral tablet taken once a day
OG001
40 mg
Lurasidone 40 mg oral tablet taken once a day
OG002
80 mg
Lurasidone 80 mg oral tablet taken once a day
OG003
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
20 mg
Lurasidone 20 mg oral tablet taken once a day
4
71
49
71
EG001
40 mg
Lurasidone 40 mg oral tablet taken once a day
9
67
51
67
EG002
80 mg
Lurasidone 80 mg oral tablet taken once a day
3
71
51
71
EG003
10 mg Haloperidol
10 mg Haloperidol overencapsulated tablet taken orally once a day
5
72
58
72
EG004
Placebo
Oral Capsule matching treatment group taken oce a day
7
72
50
72
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EG0001 events1 affected71 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected71 at risk
EG0030 events0 affected72 at risk
EG0040 events0 affected72 at risk
Grand Mal Convulsion
Nervous system disorders
EG0000 events0 affected71 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected71 at risk
EG003
Abnormal Behavior
Psychiatric disorders
EG0000 events0 affected71 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected71 at risk
EG003
Agitation
Psychiatric disorders
EG0000 events0 affected71 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected71 at risk
EG003
Anxiety
Psychiatric disorders
EG0000 events0 affected71 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected71 at risk
EG003
Schizophrenia
Psychiatric disorders
EG0002 events2 affected71 at risk
EG0018 events8 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Suicidal Ideation
Psychiatric disorders
EG0001 events1 affected71 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected71 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Discomfort
Gastrointestinal disorders
EG0001 events1 affected71 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected71 at risk
EG0035 events5 affected72 at risk
EG0041 events1 affected72 at risk
Constipation
Gastrointestinal disorders
EG0002 events2 affected71 at risk
EG0011 events1 affected67 at risk
EG0026 events6 affected71 at risk
EG003
Diarrhea
Gastrointestinal disorders
EG0003 events3 affected71 at risk
EG0012 events2 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Dyspepsia
Gastrointestinal disorders
EG0008 events8 affected71 at risk
EG0016 events6 affected67 at risk
EG0028 events8 affected71 at risk
EG003
Nausea
Gastrointestinal disorders
EG0008 events8 affected71 at risk
EG0017 events7 affected67 at risk
EG00213 events13 affected71 at risk
EG003
Toothache
Gastrointestinal disorders
EG0002 events2 affected71 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected71 at risk
EG003
Vomiting
Gastrointestinal disorders
EG0005 events5 affected71 at risk
EG0015 events5 affected67 at risk
EG00212 events12 affected71 at risk
EG003
Fatigue
General disorders
EG0005 events5 affected71 at risk
EG0012 events2 affected67 at risk
EG0029 events9 affected71 at risk
EG003
Pain
General disorders
EG0001 events1 affected71 at risk
EG0014 events4 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Nasopharyngitis
Infections and infestations
EG0003 events3 affected71 at risk
EG0012 events2 affected67 at risk
EG0021 events1 affected71 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
EG0000 events0 affected71 at risk
EG0014 events4 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
EG0000 events0 affected71 at risk
EG0014 events4 affected67 at risk
EG0025 events5 affected71 at risk
EG003
Akathisia
Nervous system disorders
EG0004 events4 affected71 at risk
EG0019 events9 affected67 at risk
EG00213 events13 affected71 at risk
EG003
Dizziness
Nervous system disorders
EG0004 events4 affected71 at risk
EG0013 events3 affected67 at risk
EG0024 events4 affected71 at risk
EG003
Dystonia
Nervous system disorders
EG0000 events0 affected71 at risk
EG0011 events1 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Extrapyramidal Disorder
Nervous system disorders
EG0003 events3 affected71 at risk
EG0014 events4 affected67 at risk
EG0024 events4 affected71 at risk
EG003
Headache
Nervous system disorders
EG00015 events15 affected71 at risk
EG00116 events16 affected67 at risk
EG00217 events17 affected71 at risk
EG003
Sedation
Nervous system disorders
EG0008 events8 affected71 at risk
EG00111 events11 affected67 at risk
EG00215 events15 affected71 at risk
EG003
Somnolence
Nervous system disorders
EG0003 events3 affected71 at risk
EG0014 events4 affected67 at risk
EG0027 events7 affected71 at risk
EG003
Tremor
Nervous system disorders
EG0001 events1 affected71 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected71 at risk
EG003
Agitation
Psychiatric disorders
EG0007 events7 affected71 at risk
EG0019 events9 affected67 at risk
EG0023 events3 affected71 at risk
EG003
Anxiety
Psychiatric disorders
EG0002 events2 affected71 at risk
EG0019 events9 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Insomnia
Psychiatric disorders
EG0006 events6 affected71 at risk
EG0015 events5 affected67 at risk
EG0024 events4 affected71 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
EG0003 events3 affected71 at risk
EG0014 events4 affected67 at risk
EG0021 events1 affected71 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
EG0004 events4 affected71 at risk
EG0013 events3 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
EG0001 events1 affected71 at risk
EG0014 events4 affected67 at risk
EG0022 events2 affected71 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Josephine Cucchiaro, Executive Director
Sunovion
201-592-2050
josephine.cucchiaro@sunovion.com
ID
Term
D012559
Schizophrenia
Ancestor Terms
ID
Term
D019967
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069056
Lurasidone Hydrochloride
D006220
Haloperidol
Ancestor Terms
ID
Term
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D054833
Isoindoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D002090
Butyrophenones
D007659
Ketones
Browse Leaves
Not provided
Browse Branches
Not provided
40.0
± 10.5
BG00441.0± 9.7
BG00541.2± 10.0
19
BG00314
BG00417
BG00591
Male
BG00051
BG00146
BG00252
BG00358
BG00455
BG005262
72
OG00471
-9.8
± 1.37
OG004-7.9± 1.38
10 mg Haloperidol
10 mg Haloperidol overencapsulated tablet taken orally once a day
OG004
Placebo
Oral Capsule matching treatment group taken oce a day
Units
Counts
Participants
OG00071
OG00165
OG00270
OG00372
OG00471
Title
Denominators
Categories
Title
Measurements
OG000-7.1± 2.31
OG001-7.2± 2.42
OG002-13.6± 2.34
OG003-16.0± 2.29
OG004-12.3± 2.32
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
ANCOVA
<0.05
2-Sided
95
No
Superiority or Other
10 mg Haloperidol overencapsulated tablet taken orally once a day
OG004
Placebo
Oral Capsule matching treatment group taken oce a day
Units
Counts
Participants
OG00071
OG00164
OG00270
OG00371
OG00471
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 0.11
OG001-0.4± 0.12
OG002-0.8± 0.12
OG003-0.8± 0.12
OG004-0.7± 0.11
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
ANCOVA
<0.05
2-Sided
95
No
Superiority or Other
10 mg Haloperidol
10 mg Haloperidol overencapsulated tablet taken orally once a day
OG004
Placebo
Oral Capsule matching treatment group taken oce a day