Back to resultsStudy on Metabolic Parameters of Sertindole in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sertindole
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Patients with schizophrenia
- Participation in 11286 study
- Capable of completing all study-related activities for the duration of the study
Sites / Locations
- CN002
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00759460
Brief Title
Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia
Official Title
An Exploratory Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Metabolic Effect of up to 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on metabolic parameters and syndrome in patients with schizophrenia.
Detailed Description
The prevalence of metabolic syndrome is estimated to be around 20-25% of the population and is particularly high in patients with schizophrenia. Individuals with metabolic syndrome are twice as likely to die from, and three times as likely to suffer from a heart attack or stroke compared to individuals without the syndrome.
Patients on atypical antipsychotic medication should be considered a high risk group for diabetes and cardiovascular disease. Weight gain is common in patients taking neuroleptics and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sertindole
Intervention Description
12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Primary Outcome Measure Information:
Title
Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with schizophrenia
Participation in 11286 study
Capable of completing all study-related activities for the duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
CN002
City
Beijing
ZIP/Postal Code
100083
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia
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