NCT00759460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

September 24, 2008

Last Update Submit

September 19, 2013

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome

    12 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Sertindole

2

ACTIVE COMPARATOR
Drug: Olanzapine

Interventions

SertindoleDRUG

12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

1
OlanzapineDRUG

10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Also known as: Zyprexa
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with schizophrenia
  • Participation in 11286 study
  • Capable of completing all study-related activities for the duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CN002

Beijing, 100083, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindoleOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

CN(1)