Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia

Tracking Information
First Submitted Date ICMJE	September 24, 2008
First Posted Date ICMJE	September 25, 2008
Last Update Posted Date	September 20, 2013
Study Start Date ICMJE	March 2007
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 24, 2008)	Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome [ Time Frame: 12 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00759460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Schizophrenia
Intervention ICMJE	Drug: Sertindole 12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days; Drug: Olanzapine 10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days Other Name: Zyprexa
Study Arms	Experimental: 1 Intervention: Drug: Sertindole; Active Comparator: 2 Intervention: Drug: Olanzapine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 24, 2008)	250
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2008
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with schizophrenia; Participation in 11286 study; Capable of completing all study-related activities for the duration of the study
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00759460
Other Study ID Numbers ICMJE	11286C
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	H. Lundbeck A/S
Study Sponsor ICMJE	H. Lundbeck A/S
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account	H. Lundbeck A/S
Verification Date	September 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP