NCT00861497

TerminatedPhase 3

Bifeprunox Extension to Extension Study in Patients With Sch...

H. Lundbeck A/S Source

H. Lundbeck A/S

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

11051

Secondary identifiers

2005-000497-50

EUDRACT_NUMBER

2005

NIH

Study Type

interventional

Actual enrollment (reported)

11

Locations

1 country

Sites

1

Timeline

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2008

Actual (reported)

Study Completion

July 2009

Actual (reported)

Brief Summary

The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 11 participants
Study completion date: July 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)
First Submitted
March 12, 2009
Actual (reported)
First Posted
March 13, 2009
Actual (reported)
Study Completion
July 2009
Actual (reported)

Last Updated: September 16, 2013
Status Verified: September 2013
Last Update Submitted: September 13, 2013

Conditions

Schizophrenia

Keywords

Open-labelFlexible-doseExtensionSafety study

Outcome Measures

Primary Outcomes (1)

Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)
Assessments every 4 to 8 weeks

Secondary Outcomes (1)

CGI-S
Assessments every 4 to 8 weeks

Study Arms (1)

Bifeprunox

EXPERIMENTAL

Drug: Bifeprunox

Interventions

BifeprunoxDrug

Flexible dosage: 20, 30, or 40 mg/day

Bifeprunox

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients, suffering from schizophrenia, having completed studies 10206 or 10265
Otherwise healthy

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrycollaborator
H. Lundbeck A/S
Industrylead

Study Sites (1)

IT001

Brescia, 25123, Italy

MeSH Terms

Conditions

Schizophrenia

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
STUDY DIRECTOR

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT00658645

Efficacy of Bifeprunox in Patients With Schizophrenia

Phase 3Terminated

NCT00704509

Efficacy of Bifeprunox in Patients With Schizophrenia

Phase 3Terminated

NCT00230828

Patient-reported Outcomes in the Treatment of Schizophrenia

Phase 3Completed

NCT00366704

Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

Phase 3Terminated

NCT00396214

Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

Phase 3Terminated

NCT00380224

Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

Phase 3Completed

Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception

The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)

You may not qualify if:

Current Axis I primary psychiatric diagnosis other than schizophrenia
Significant risk of suicide and/or violent behaviour
Other psychiatric, neurological or behavioural disorders that may interfere with study conduct
Substance or alcohol abuse, current cannabis dependence
Clinically significant physical illness

Contact the study team to confirm eligibility.

Primary Completion

January 2008

Actual (reported)

Study Completion

July 2009

Actual (reported)

Last Updated

September 16, 2013

Record last verified: 2013-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00861497
Data provider: ClinicalTrials.gov
Source updated: 2013-09-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:10 UTC

Locations

IT(1)

Study Stopped

Bifeprunox Extension to Extension Study in Patients With Schizophrenia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Bifeprunox

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Bifeprunox

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations