SchizophreniaPhase 3NCT00174447

Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Schizophrenia
What is being tested?: Ziprasidone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 14 sitesFrance
Study dates: Oct 2001to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Who cannot join

All other patients who do not fit the inclusion criteria as stated above.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

France14 sites

Pfizer Investigational Site
Avignon, 84000
Pfizer Investigational Site
DOLE Saint YLIE, 39108
Pfizer Investigational Site
Liévin, 62800
Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Montfavet, 84143
Pfizer Investigational Site
Orvault, 44700
Pfizer Investigational Site
Rennes, 35000
Pfizer Investigational Site
Saint-Égrève, 38521
Pfizer Investigational Site
Saint-Rémy, 70160
Pfizer Investigational Site
Strasbourg, 67100
Pfizer Investigational Site
Toulon, 83056
Pfizer Investigational Site
Toulouse, 31000
Pfizer Investigational Site
Toulouse, 31200
Pfizer Investigational Site
Versailles, 78000

Other trials in France

About this study

Official title: Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

Conditions: Schizophrenia
Being tested: Ziprasidone
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZiprasidoneDrug
Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

Study groups in NCT00174447
Study group	Role	What they receive
A1	Experimental	Not described Receives: Drug: Ziprasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Measured: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
Change From Baseline in CGI-I at End of Study (up to 5 Years)
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
Measured: Baseline, up to 5 years (End of Study [LOCF])
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Measured: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
Change From Baseline in CGI-S at End of Study (up to 5 Years)
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
Measured: Baseline, up to 5 years (End of Study [LOCF])

Secondary outcomes (2)

Number of Participants With Scores on Patient Preference Scale (PPS)
Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.
Measured: Baseline, up to 5 years (End of Study)
Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)
DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.
Measured: Baseline, up to 5 years (End of Study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2001Oct 2008

First posted15 Sep 2005 (estimated)
Study startOct 2001
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00174447
Sponsor's protocol ID: A1281060
Status last verified: Mar 2021
First submitted: 12 Sep 2005
Last updated: 24 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Geier JL, Karayal ON, Lewis M, Camm JA, Keane M, Kremer CM, Kolluri S, Reynolds R, Eng S, Strom BL. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1192-8. doi: 10.1002/pds.2185. Epub 2011 Jul 27.
PubMed 21796719
Strom BL, Faich GA, Reynolds RF, Eng SM, D'Agostino RB, Ruskin JN, Kane JM. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry. 2008 Jan;69(1):114-21. doi: 10.4088/jcp.v69n0115.
PubMed 18312045

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031
ClinicalTrials.gov ID: NCT00174447
Acronym / sponsor ID: A1281060
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2001
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 17 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A1	Experimental	Drug: Ziprasidone

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Key exclusion criteria (1 listed)

All other patients who do not fit the inclusion criteria as stated above.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZiprasidoneDosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid	Drug	A1

Primary outcome

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Change From Baseline in CGI-I at End of Study (up to 5 Years)
Time frame: Baseline, up to 5 years (End of Study [LOCF])
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Change From Baseline in CGI-S at End of Study (up to 5 Years)
Time frame: Baseline, up to 5 years (End of Study [LOCF])
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.

2 secondary outcomes

Number of Participants With Scores on Patient Preference Scale (PPS)
Time frame: Baseline, up to 5 years (End of Study)
Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)
Time frame: Baseline, up to 5 years (End of Study)

Results and safety

Results posted to the registry on 17 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ziprasidone	43	5

Primary outcome: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]. Number. Unit: participants

Measure	Ziprasidone n = 43
Baseline (n=43): very much improved	13
Baseline (n=43): much improved	30
3 months (n=35): very much improved	10
3 months (n=35): much improved	20
3 months (n=35): minimally improved	2
3 months (n=35): no change	3
6 months (n=34): very much improved	11
6 months (n=34): much improved	18

Population analysed: Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).

Primary outcome: Change From Baseline in CGI-I at End of Study (up to 5 Years)

Time frame: Baseline, up to 5 years (End of Study [LOCF]). Mean (Standard Deviation). Unit: score on a scale

Measure	Ziprasidone n = 43
Value	1.4 (1.6)

Population analysed: ITT. LOCF.

Primary outcome: Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]. Number. Unit: participants

Measure	Ziprasidone n = 43
Baseline (n=43): normal, not ill at all	4
Baseline (n=43): borderline	20
Baseline (n=43): mildly ill	14
Baseline (n=43): moderately ill	4
Baseline (n=43): markedly ill	1
3 months (n=35): normal, not ill at all	6
3 months (n=35): borderline	13
3 months (n=35): mildly ill	10

Population analysed: ITT. LOCF.

Primary outcome: Change From Baseline in CGI-S at End of Study (up to 5 Years)

Time frame: Baseline, up to 5 years (End of Study [LOCF]). Mean (Standard Deviation). Unit: score on a scale

Measure	Ziprasidone n = 43
Value	0.9 (1.5)

Population analysed: ITT. LOCF.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziprasidone	13 of 43 (30.2%)	36 of 43 (83.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21796719Geier JL, Karayal ON, Lewis M, Camm JA, Keane M, Kremer CM, Kolluri S, Reynolds R, Eng S, Strom BL. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1192-8. doi: 10.1002/pds.2185. Epub 2011 Jul 27.
Derived from this study: PubMed 18312045Strom BL, Faich GA, Reynolds RF, Eng SM, D'Agostino RB, Ruskin JN, Kane JM. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry. 2008 Jan;69(1):114-21. doi: 10.4088/jcp.v69n0115.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) (time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00174447, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.