NCT00763438

Brief Summary

The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2007

Typical duration for phase_4 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

November 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

September 30, 2008

Last Update Submit

November 7, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaSertindoleSafety study

Outcome Measures

Primary Outcomes (1)

  • All serious adverse events reported; visits scheduled every 3 months

    Every 3 months

Study Arms (1)

Sertindole

EXPERIMENTAL
Drug: Sertindole

Interventions

SertindoleDRUG

Flexible dose

Sertindole

Eligibility Criteria

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

You may qualify if:

  • Participation in the previous SCoP study, 99824
  • Still fulfils the EU SPC requirements for Sertindole

You may not qualify if:

  • Withdrawn before the end of the SCoP study, 99824
  • Become homeless
  • Participation in another clinical trial at the same time
  • Unlikely to comply with the clinical study protocol or is unsuitable for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FR002

Allonnes, 72703, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

FR(1)